Closure element for use with an annuloplasty structure

ABSTRACT

Apparatus and methods are described including an implant structure configured to treat a native atrioventricular valve of a patient, the implant structure including a sleeve having a lumen and at least one end, the at least one end being shaped so as to define an opening. A closure element is disposed in a vicinity of the at least one end, the closure element being configured to facilitate closure of the opening. A contracting mechanism is coupled to the implant structure and configured to contract at least a contraction-facilitated portion of the implant structure. Other applications are also described.

FIELD OF THE INVENTION

Some embodiments of the present invention relate in general to valverepair, and more specifically to repair of an atrioventricular valve ofa patient.

BACKGROUND

Ischemic heart disease causes mitral regurgitation by the combination ofischemic dysfunction of the papillary muscles, and the dilatation of theleft ventricle that is present in ischemic heart disease, with thesubsequent displacement of the papillary muscles and the dilatation ofthe mitral valve annulus.

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Mitral regurgitation ofblood from the left ventricle into the left atrium results in increasedtotal stroke volume and decreased cardiac output, and ultimate weakeningof the left ventricle secondary to a volume overload and a pressureoverload of the left atrium.

SUMMARY

In some applications of the present invention, apparatus is providedthat comprises an implant structure comprising a sleeve having a lumenand at least one opening at a first end of the implant structure. Theimplant structure additionally comprises a closure element (e.g., aclosure mechanism) configured to close the at least one opening at thefirst end of the implant structure. The implant structure comprises acontracting mechanism configured to contract and expand the implantstructure at least in part. For some applications, the closure mechanismcomprises at least one end flap, and the contracting mechanism isconfigured to actuate the end flap so as to cover the at least oneopening. For other applications, the closure mechanism comprisesself-closing strips which are biased to close around the portion of theimplant structure that defines the at least one opening.

Typically, the implant structure comprises at least part of anannuloplasty structure (e.g., a partial annuloplasty ring) for repairinga dilated valve annulus of a native atrioventricular valve, such as amitral valve, of a patient. One or more flexible, longitudinalcontracting members (e.g., a wire, string, or suture) are coupled to thesleeve of the implant structure by being threaded one or more timesthrough the sleeve. Additionally, the contracting member is coupled at afirst portion thereof to the contracting mechanism. For applications inwhich the closure mechanism comprises the end flap, a second portion ofthe contracting member is coupled to the end flap. When the contractingmechanism is actuated in a first actuation direction, the contractingmechanism pulls on the contracting member which, in turn, pulls on theend flap, thereby covering the opening at least in part. One or morecontraction-restricting elements are coupled to the implant structureand/or to the contracting member. The one or morecontraction-restricting elements are configured to restrict contractionof at least a first portion of the implant structure beyond apredetermined amount while the contraction of the remaining portion(s)of the implant structure is ongoing.

The contracting mechanism comprises a rotatable structure, arranged suchthat rotation of the rotatable structure adjusts a perimeter of theimplant structure. A longitudinal guide member (e.g., a wire, string, orsuture) is coupled to the rotatable structure. A rotation tool isprovided for rotating the rotatable structure. The tool is configured tobe guided along (e.g., over, alongside, or through) the longitudinalguide member, to engage the rotatable structure, and to rotate therotatable structure in response to a rotational force applied to thetool.

In some applications of the present invention, the apparatus comprises aplurality of anchors. An anchor deployment manipulator is advanced intoa lumen of the sleeve, and, from within the lumen, deploys the anchorsthrough a wall of the sleeve and into cardiac tissue, thereby anchoringthe sleeve around a portion of the valve annulus. The anchor deploymentmanipulator is typically deflectable.

In some applications of the present invention, the anchor deploymentmanipulator comprises a steerable tube in which is positioned an anchordriver having an elongated, flexible shaft. Rotation of the anchordriver screws the anchors into the cardiac tissue. The anchors may, forexample, be helical in shape. One or more stiffening elements, e.g.,wires or sutures, are threaded through one or more portions of thesleeve in order to maintain relative positioning of the anchor driverrelative to the implant structure during deflection of the anchor driverwithin the sleeve.

For some applications, the annuloplasty ring is typically configured tobe placed only partially around the valve annulus (e.g., to assume aC-shape), and, once anchored in place, to be contracted so as tocircumferentially tighten the valve annulus. To this end, theannuloplasty ring comprises the flexible contracting member. For someapplications of the present invention, the implant structure comprisesone or more contraction-restricting elements configured to restrictcontraction of at least a portion of the implant structure. Thus, theimplant structure is partially-contractible.

Typically, a first anchor is deployed at or in a vicinity of a firsttrigone of the valve, and a second anchor is deployed at or in avicinity of a second trigone. For valves which are particularlydistended, the implant structure is anchored to the first trigone at afirst free end thereof and is anchored to the second trigone at a secondfree end thereof. For applications in which the implant structure isimplanted along an annulus of a mitral valve, the body portion of theimplant structure extends from the first trigone and toward and along aportion of the annulus that is adjacent to the posterolateral leaflet.For such an application, the contraction-restricted portion is disposedalong the annulus and therefore, a portion of the implant structure iscontracted (i.e., a contraction-facilitated portion), therebycontracting a portion of the annulus that is between the first andsecond trigones and adjacent to the posterolateral leaflet and, thereby,reducing a perimeter of the valve annulus and drawing the leafletstogether.

For other applications, the second free end is not anchored to thetrigone, but is instead anchored to a portion of the atrial wall (e.g.,a portion of the interatrial septum or a portion of a free wall) of theheart of the patient while the first free end or a first portion of theimplant structure adjacent the first free end is anchored to the firsttrigone. For some applications, the entire contraction-restrictedportion is attached to the portion of the atrial wall and thecontraction-facilitated portion is disposed between the first and secondtrigones and runs along the portion of the annulus that is adjacent tothe posterolateral leaflet. For such applications in which the implantstructure is implanted at the mitral valve, the entire portion of theannulus that is between the first and second trigones and adjacent theposterolateral leaflet is contracted, thereby reducing a perimeter ofthe valve annulus and drawing the leaflets together.

For some applications, the contracting mechanism comprises a spool towhich a first end of the contracting member is coupled. Rotation of thespool winds a portion of the contracting member around the spool,thereby contracting the implant structure. For some applications, thecontracting mechanism comprises a housing that houses the spool, and therotation tool is configured to engage and rotate the spool with respectto the housing. For some applications, the rotation tool comprises atube, which is configured to be passed over the longitudinal membercoupled to the contracting mechanism, and to engage the housing, suchthat the housing is held rotationally stationary when the tube is heldrotationally stationary.

For some application in which the implant structure comprises anannuloplasty ring, all of the tools and elements of the annuloplastysystem that are introduced into left atrium are contained within thesleeve of the annuloplasty ring, which reduces the risk that anyelements of the system will accidentally be released to the bloodcirculation, or damage surrounding tissue. In addition, the lumen of thesleeve provides guidance if it should be necessary to return to apreviously deployed anchor, such as to tighten, loosen, remove, orrelocate the anchor. For some applications, the anchors comprise helicalscrews, which facilitate such adjusting or removing.

The annuloplasty ring may be advanced toward the annulus of a valve inany suitable procedure, e.g., a transcatheter procedure, a percutaneousprocedure, a minimally invasive procedure, or an open heart procedure.

There is therefore provided, in accordance with some applications of thepresent invention, apparatus, including:

an implant structure configured to treat a native atrioventricular valveof a patient, the implant structure including:

-   -   a sleeve having a lumen and at least one end, the at least one        end being shaped so as to define an opening; and    -   a closure element disposed in a vicinity of the at least one        end, the closure element being configured to facilitate closure        of the opening; and    -   a contracting mechanism coupled to the implant structure and        configured to contract at least a contraction-facilitated        portion of the implant structure.

For some applications, the implant structure has a length of between 50mm and 150 mm.

For some applications, the implant structure has a diameter of between 1mm and 10 mm.

For some applications, the apparatus is configured to be implanted alongan annulus of a mitral valve of the patient in a manner in which theimplant structure is formed into at least a portion of an annuloplastyring.

For some applications, the closure element includes a closure mechanismthat includes one or more strips coupled to the sleeve in the vicinityof the at least one end of the sleeve, and the one or more strips have atendency to be in a closed state in which the one or more strips closearound at least a portion of the opening.

For some applications, the apparatus further includes a delivery tooladvanceable within the lumen of the sleeve through the opening, and thetool is configured to expand the one or more strips while advanceablewithin the lumen of the sleeve and to facilitate positioning of the oneor more strips in the closed state when removed from within the lumen ofthe sleeve.

For some applications, the apparatus further includes a contractingmember coupled to the sleeve that facilitates contraction of thecontraction-facilitated portion of the implant structure, thecontracting member having a first portion thereof that is coupled to thecontracting element.

For some applications, the contracting member is threaded through thesleeve one or more times to facilitate generally-even contraction of theimplant structure.

For some applications, the apparatus further includes one or morecontraction-restricting elements coupled to at least acontraction-restricted portion of the implant structure, the one or morecontraction-restricting elements being configured to restrictcontraction of at least the contraction-restricted portion of theimplant structure beyond a predetermined amount.

For some applications, the one or more contraction-restricting elementsis coupled to an outer surface of the implant structure.

For some applications, each one of the one or morecontraction-restricting elements includes a segment having at least aportion thereof that is non-compressible along a longitudinal axis ofthe segment.

For some applications, at least one of contraction-restricting elementsis disposed adjacently to one or more contraction-facilitated elementsthat are compressible along the longitudinal axis of the segment andfacilitate contraction of respective portions of the implant structurein vicinities of the one or more contraction-facilitating elements.

For some applications, each one of the contraction restriction-elementsis configured to restrict contraction of the contraction-restrictedportion of the implant structure while facilitating radial movement ofthe contraction-restricted portion of the implant structure.

For some applications, at least one of the contraction-restrictingelements includes a coiled element, and at least a portion of the coiledelement is non-compressible.

For some applications, the coiled element includes a shape-memorymaterial and is configured to be generally straightened from a coiledstate during delivery of the implant structure to an implantation siteof a body of the patient.

For some applications, the coiled element includes an elongate coiledelement disposed within the lumen of the sleeve.

For some applications, the coiled element includes an elongate coiledelement that is coupled to a portion of an outer surface of the sleeveand is disposed alongside the portion of the outer surface of thesleeve.

For some applications, the implant is configured for implantation alonga native annulus of the native atrioventricular valve of the patient ina manner in which the contraction-restricted portion of the implantstructure is disposed along a portion of the annulus at a posteriorleaflet of the valve, and the contraction-restricting element is coupledto the contraction-restricted portion.

For some applications, the contraction restriction-element is configuredto restrict contraction of the contraction-restricted portion whilefacilitating radial movement of the contraction-restricted portion.

For some applications:

-   -   the closure element includes at least one end flap that is        disposed at the at least one end of the sleeve, and    -   the first portion of the contracting member is coupled to the        end flap in a manner in which, in response to at least initial        actuation of the contracting mechanism, the contracting member        draws the end flap at least partially over the opening at the at        least one end of the sleeve.

For some applications, the one or more contraction-restricting elementseach have a length of between 3 and 120 mm.

For some applications:

-   -   the one or more contraction-restricting elements are coupled to        the contracting member in a vicinity of the first portion        thereof,    -   the one or more contraction-restricting elements are disposed        along the implant structure at a distance of between 3 and 45 mm        from the at least one end of the sleeve,    -   the contraction-restricted portion of the implant structure is        between 3 and 45 mm from the at least one end of the sleeve, and    -   the one or more contraction-restricting elements are configured        to restrict contraction of the contraction-restricted portion of        the implant structure during contraction of a remaining portion        of the implant structure by the contracting member.

For some applications, the contracting mechanism is disposed at a firstportion of the implant structure, and the contracting member extendsalong the implant structure from the first portion thereof to the atleast one end of the sleeve.

For some applications, the one or more contraction-restricting elementsare disposed in a vicinity of the at least one end of the sleeve, andthe contracting member is looped through a portion of the flap andextends back toward the one or more contraction-restricting elements.

For some applications, the contracting mechanism includes a rotatablestructure, and the actuation includes rotation of the rotatablestructure in a first rotational direction in order to actuate thecontracting member to draw the flap over the opening.

For some applications, in response to rotation of the rotatablestructure in a second rotational direction that is opposite the firstrotational direction, the contracting member draws the end flap at leastpartially away from the opening at the at least one end of the sleeve.

For some applications:

-   -   the at least one end of the sleeve defines a first free end of        the implant structure,    -   the implant structure is shaped so as to define a second free        end, the apparatus is configured to be implanted along an        annulus of an atrioventricular valve of the patient, and    -   in response to actuation of the contracting mechanism, the first        and second free ends of the implant structure are drawn toward        one another.

For some applications, the apparatus is configured to be implanted alongan annulus of a mitral valve of the patient,

-   -   the first end of the implant structure is configured to be        coupled to a first location along the annulus in a vicinity of a        first trigone adjacent to the mitral valve, and    -   the second end of the implant structure is configured to be        coupled to a second location along the annulus in a vicinity of        a second trigone adjacent to the mitral valve.

For some applications, the contracting mechanism includes a rotatablestructure, and the actuation includes rotation of the rotatablestructure in a first rotational direction to contract the implantstructure.

For some applications, in response to rotation of the rotatablestructure in a second rotational direction that is opposite the firstrotational direction, the contracting member expands the implantstructure.

For some applications, in response to rotation of the rotatablestructure in a first rotational direction, successive portions of thecontracting member advance in a first advancement direction with respectto the rotatable structure and contact the rotatable structure.

For some applications, the rotatable structure includes a spool, and, inresponse to the rotation of the spool in the first rotational direction,the contracting member is configured to be wound around the spool.

For some applications, in response to continued advancement of thecontracting member in the first advancement direction by continuedrotation of the rotatable structure in the first rotational direction,the at least one end of the sleeve is pulled toward the contractingmechanism.

For some applications:

the implant structure is configured to be implanted along an annulus ofa mitral valve of the patient,

the contracting member is configured to contract the implant structurein response to the rotation of the rotatable structure in the firstrotational direction, and

the implant structure is configured to contract the annulus in responseto the contraction of the implant structure.

For some applications, the successive portions of the contracting memberare configured to be advanced in a second advancement direction withrespect to the rotatable structure and thereby to facilitate expansionof the implant structure in response to rotation of the rotatablestructure in a second rotational direction, the second rotationaldirection being opposite the first rotational direction, and the secondadvancement direction being opposite the first advancement direction.

For some applications:

the rotatable structure has a first end shaped to define a firstopening, and a second end shaped to define a second opening, therotatable structure being shaped to define a channel extending from thefirst opening to the second opening, the channel being configured forpassage therethrough of an elongate tool, and

the second end of the rotatable structure has a lower surface thereofshaped to define one or more recesses.

For some applications, the apparatus further includes a mechanicalelement having a planar surface coupled to the lower surface of therotatable structure, the mechanical element being shaped to provide:

-   -   a protrusion protruding out of a plane of the planar surface of        the mechanical element, the protrusion being disposed within one        of the recesses during a resting state of the mechanical        element, in a manner that restricts rotation of the rotatable        structure, and    -   a depressible portion coupled to the protrusion, the depressible        portion being disposed in communication with the second opening        of the lower surface, and configured to dislodge the protrusion        from within the recess in response to a force applied thereto by        the elongate tool.

For some applications, the apparatus further includes:

one or more tissue anchors; and

a deployment manipulator tube, which is configured to be removablypositioned at least partially within the lumen of the sleeve, such thatthe deployment manipulator tube extends out of the at least one end ofthe sleeve; and

an anchor driver which is reversibly coupleable to the one or moretissue anchors and which is configured to be at least partiallypositioned within the deployment manipulator tube, and, while sopositioned, to deploy the one or more tissue anchors through a wall ofthe sleeve.

For some applications, the anchor driver is deflectable within thesleeve of the implant structure, and the apparatus further includes oneor more stiffening elements, the one or more stiffening elements beingthreaded through one or more portions of the sleeve in order to maintainrelative positioning of the manipulator tube relative to the implantstructure during deflection of the anchor driver within the sleeve.

For some applications, the manipulator tube is deflectable within thesleeve of the implant structure, and the one or more stiffening elementsare configured to maintain relative positioning of the implant structurerelative to the manipulator tube during deflection of the manipulatortube.

For some applications, the apparatus further includes a pusher tube,which is configured to pass over a portion of the deployment manipulatortube, such that a distal end of the pusher tube is in contact with theat least one end of the sleeve.

For some applications, the distal end of the pusher tube is removablycoupled to the at least one end of the sleeve.

For some applications, the pusher tube includes one or more couplingelements, which are configured to removably couple the distal end of thepusher tube to the at least one end of the sleeve.

For some applications, the apparatus is configured such that:

when the deployment manipulator tube is positioned within the lumen ofthe sleeve, the deployment manipulator tube causes the coupling elementsto engage the sleeve, thereby removably coupling the distal end of thepusher tube to the at least one end of the sleeve, and

when the deployment manipulator tube is withdrawn from the sleeve, thecoupling elements disengage from the sleeve, thereby decoupling thedistal end of the pusher tube from the at least one end of the sleeve.

For some applications, the coupling elements are configured to have anatural tendency to flex inwards toward a central longitudinal axis ofthe sleeve that passes through the at least one end of the sleeve, andthe deployment manipulator tube, when positioned within the lumen of thesleeve, pushes the coupling elements outwards away from the longitudinalaxis, thereby causing the coupling elements to engage the sleeve.

There is further provided, in accordance with some applications of thepresent invention, apparatus, including:

an implant structure configured to treat a native atrioventricular valveof a patient, the implant structure including:

-   -   a sleeve having a lumen and at least one end, the at least one        end being shaped so as to define an opening; and    -   a closure element disposed in a vicinity of the at least one        end, the closure element being configured to facilitate closure        of the opening; and

an anchor delivery tool advanceable through the opening and within thelumen of the sleeve when the closure element does not facilitate closureof the opening.

There is additionally provided in accordance with some applications ofthe present invention, apparatus, including:

an implant structure configured to treat a native atrioventricular valveof a patient, the implant structure having a length of between 50 mm and150 mm and a diameter of between 1 mm and 10 mm, the implant structureincluding:

-   -   a sleeve having a lumen and at least one end, the at least one        end being shaped so as to define an opening; and    -   a closure element disposed in a vicinity of the at least one        end, the closure element being configured to facilitate closure        of the opening.

There is further provided, in accordance with some applications of thepresent invention, a method, including:

positioning an implant structure along an annulus of an atrioventricularvalve of a patient, the implant structure including a sleeve having alumen and at least one end, the at least one end being shaped so as todefine an opening;

fastening at least a portion of the implant structure to the annulus;and

closing the opening of the at least one end of the sleeve by actuating aclosure element of the implant structure to close.

For some applications, positioning the implant structure along theannulus of the atrioventricular valve includes transcatheterallypositioning the implant structure along the annulus of theatrioventricular valve.

For some applications, the method further includes driving one or moretissue anchors through a wall of the sleeve from within the lumen of thesleeve.

For some applications, positioning the implant structure along theannulus of the atrioventricular valve includes positioning the implantstructure along the annulus in a manner in which the implant structureis formed into a least a portion of an annuloplasty ring.

For some applications, the closure element includes a closure mechanismthat includes one or more strips coupled to the sleeve in a vicinity ofthe at least one end of the implant structure, the one or more stripshave a tendency to be in a closed state in which the one or more stripsclose around at least a portion of the opening, and the method furtherincludes:

expanding the one or more strips from the closed state by introducing atool within the lumen of the sleeve, and

facilitating positioning of the one or more strips in the closed stateby extracting the tool from within the lumen of the sleeve.

For some applications, fastening includes:

anchoring a first location of the implant structure to a first trigoneof the valve; and

anchoring a second location of the implant structure to a second trigoneof the valve.

For some applications, anchoring the first location includes anchoring afirst free end of the implant structure to the first trigone, andanchoring the second location includes anchoring a second free end ofthe implant structure to the second trigone.

For some applications, the method further includes contracting at leasta first portion of the implant structure by actuating a contractingmechanism coupled to the implant structure.

For some applications, the method further includes restricting thecontracting of at least a second portion of the implant structure thatis less than the entire implant structure, during ongoing contracting ofthe first portion of the implant structure.

For some applications, restricting the contracting of the second portionof the implant structure includes restricting contraction of acontraction-restricted portion of the implant structure that has alength of between 3 mm and 120 mm.

For some applications, restricting the contracting includes coupling tothe second portion of the implant structure a segment having at least aportion thereof that is non-compressible along a longitudinal axis ofthe segment.

For some applications, coupling the segment to the second portion of theimplant structure includes coupling the segment to an outer surface ofthe implant structure in a vicinity of the second portion of the implantstructure.

For some applications, coupling the segment to the outer surface of theimplant structure includes restricting contraction of the portion of theimplant structure while facilitating radial movement of the portion ofthe implant structure.

For some applications, positioning the implant structure along theannulus of the atrioventricular valve includes positioning the implantstructure in a manner in which the second portion of the implantstructure is disposed along a portion of the annulus at a posteriorleaflet of the valve, and restricting contraction of the second portionof the implant structure includes restricting contraction of the portionof the annulus at the posterior leaflet of the valve.

For some applications, restricting the contracting of the second portionof the implant structure includes advancing into at least a portion ofthe lumen of the sleeve, a segment having at least a portion thereofthat is non-compressible along a longitudinal axis of the segment.

For some applications, advancing the segment into the portion of thelumen of the sleeve includes advancing a segment that is disposedadjacently to one or more portions that are compressible along thelongitudinal axis of the segment.

For some applications, advancing the segment into the portion of thelumen of the sleeve includes advancing a coiled segment into the portionof the sleeve.

For some applications, the method further includes, prior to advancingthe coiled segment within the sleeve, advancing the coiled segmenttoward the sleeve in a generally straightened configuration, andadvancing the coiled segment into the portion of the sleeve includesallowing the segment to form a coil within the sleeve.

For some applications, advancing the segment into the portion of thelumen of the sleeve includes restricting contraction of the secondportion of the implant structure while facilitating radial movement ofthe second portion of the implant structure.

For some applications, positioning the implant structure along theannulus of the atrioventricular valve includes positioning the implantstructure in a manner in which the second portion of the implantstructure is disposed along a portion of the annulus at a posteriorleaflet of the valve, and restricting contraction of the second portionof the implant structure includes restricting contraction of the portionof the annulus at the posterior leaflet of the valve.

For some applications, restricting the contracting of the second portionof the implant structure includes restricting contraction of acontraction-restricted portion of the implant structure that is between3 and 45 mm from the at least one end of the sleeve, while facilitatingcontraction of a contraction-facilitated portion of the implantstructure.

For some applications:

the at least one end of the sleeve defines a first free end of theimplant structure,

the implant structure defines a second free end, and the method furtherincludes:

-   -   fastening the implant structure to a first trigone of the valve        by fastening the implant structure to the valve in a vicinity of        the first free end; and    -   fastening the implant structure to a second trigone of the valve        by fastening the implant structure to the valve in a vicinity of        the second free end.

For some applications:

fastening the implant structure to the first trigone includes fasteningthe first free end of the of the implant structure to the first trigone,

fastening the implant structure to the second trigone includes fasteningthe second free end of the of the implant structure to the secondtrigone,

fastening the at least the portion of implant structure to the annulusincludes fastening the entire implant structure along the annulusbetween the first and second trigones, and

contracting the first portion of the implant structure includescontracting the contraction-facilitated portion of the implant structurethat is between the second end and the contraction-restricted portion ofthe implant structure.

For some applications:

fastening the implant structure to the first trigone includes:

-   -   fastening the first free end of the of the implant structure to        a portion of an atrial wall of a heart of the patient, and    -   fastening a portion of the implant structure that is adjacent to        the first free end to the first trigone, and

anchoring the implant structure to the second trigone includes anchoringthe second free end of the of the implant structure to the secondtrigone.

For some applications:

fastening the first free end of the of the implant structure to theportion of the atrial wall includes fastening the contraction-restrictedportion of the implant structure to the portion of the atrial wall,

fastening the portion of the implant structure to the annulus includesfastening the contraction-facilitated portion of the implant to aposterior portion of the annulus between the first and second trigones,and

contracting the implant structure includes contracting thecontraction-facilitated portion of the implant structure that is betweenthe first and second trigones.

For some applications:

the atrioventricular valve includes a mitral valve;

the at least one end of the sleeve defines a first end of the implantstructure,

the implant structure is shaped so as to define a second end, and

positioning the implant structure along the annulus includes:

-   -   positioning the first end of the implant structure at a first        trigone of the mitral valve; and    -   positioning the second end of the implant structure at a second        trigone of the mitral valve.

For some applications, contracting the first portion of the implantstructure includes drawing the first and second ends of the implantstructure toward one another.

For some applications, actuating the contracting mechanism includesrotating a rotatable structure of the contracting mechanism, andcontracting the implant includes rotating the rotatable structure in afirst rotational direction.

For some applications, the method further includes locking thecontracting mechanism during a period that is subsequent to the rotatingof the rotating structure.

For some applications, the closure element includes a flap at a vicinityof the opening of the sleeve, and the method further includes at leastpartially drawing the flap over the opening during a first period, byrotating the rotating mechanism in the first rotational direction.

For some applications, the method further includes, during a secondperiod, drawing the end flap at least partially away from the opening atthe at least one end of the sleeve by rotating the rotatable structurein a second rotational direction that is opposite the first rotationaldirection.

For some applications, responsively to rotating the rotatable structure,advancing in a first advancement direction with respect to the rotatablestructure successive portions of a contracting member that is coupled tothe implant structure, the contracting member is and is configured tocontract the implant structure.

For some applications, the rotatable structure includes a spool, andadvancing the successive portions of the contracting member in the firstadvancement direction includes winding the successive portions of thecontracting member around the spool.

For some applications, contracting the first portion of the implantstructure includes rotating further the rotatable member and advancingfurther successive portions of the contracting member in the firstadvancement direction, and the contracting includes drawing the at leastone end of the sleeve toward the contracting mechanism.

For some applications, contracting the implant structure includescontracting the annulus of the atrioventricular valve.

For some applications, the method further includes expanding the implantstructure by advancing the successive portions of the contracting memberin a second advancement direction that is opposite the first advancementdirection by rotating the rotatable structure in a second rotationaldirection that is opposite the first rotational direction.

For some applications, fastening the at least the portion of the implantstructure to the annulus includes:

removably positioning a deployment manipulator tube through the openingand at least partially within the lumen of the sleeve of the implantstructure, such that the deployment manipulator tube extends out of theat least one end of the sleeve; and

driving one or more tissue anchors through a wall of the sleeve fromwithin the lumen of the sleeve.

For some applications:

driving the one or more anchors includes advancing through thedeployment manipulator tube an anchor driver that is reversiblycouplable to the one or more anchors,

exposing a distal end of the anchor driver from within a distal end ofthe deployment manipulator tube; and

deflecting through the sleeve the distal end of the anchor driver.

For some applications, the method further includes maintaining relativepositioning of the implant structure relative to the manipulator tubeduring the deflecting by applying a force to one or more stiffeningelements that are threaded through the sleeve of the implant structure.

For some applications, the method further includes placing a pusher tubeover the deployment manipulator tube such that a distal end of thepusher tube is in contact with the at least one end of the sleeve.

For some applications, the at least one end of the sleeve includes aproximal end of the sleeve, and the method further includes withdrawingthe sleeve from the deployment manipulator tube in a distal direction,and, while withdrawing, pushing the pusher tube against the proximal endof the sleeve.

For some applications, the method further includes, following thewithdrawing, removably coupling the distal end of the pusher tube to theproximal end of the sleeve.

For some applications, removably coupling includes using one or more oneor more coupling elements of the pusher tube to removably couple thedistal end of the pusher tube to the proximal end of the sleeve.

For some applications, removably coupling includes positioning thedeployment manipulator tube within the lumen of the sleeve such that thedeployment manipulator tube causes the coupling elements to engage thesleeve, and the method further includes decoupling the distal end of thepusher tube from the proximal end of the sleeve by withdrawing thedeployment manipulator tube from the sleeve such that the couplingelements disengage from the sleeve.

For some applications, positioning the implant structure along theannulus, and closing the opening of the at least one end of the sleeveinclude positioning the implant structure along the annulus, and closingthe opening of the at least one end of the sleeve during a singleprocedure.

For some applications, positioning the implant structure along theannulus, and closing the opening of the at least one end of the sleeveinclude positioning the implant structure along the annulus, and closingthe opening of the at least one end of the sleeve via a single catheter.

There is further provided, in accordance with some applications of thepresent invention, apparatus, including:

an annuloplasty structure configured for implantation along an annulusof an atrioventricular valve of a heart of a subject, the structureincluding:

-   -   a coiled element including:    -   at least one first portion thereof which is flexible and        longitudinally compressible; and    -   at least one second portion thereof in series with the first        portion, the second portion being flexible and less        longitudinally compressible than the first portion.

For some applications, the coiled element is shaped such that a pitch ofthe coiled element at the second portion is smaller than a pitch of thecoiled element at the first portion.

For some applications, a radius of curvature at a center of the firstportion is smaller than a radius of curvature at a center of the secondportion, when no external force is applied to the annuloplastystructure.

For some applications, the annuloplasty structure includes anannuloplasty ring.

For some applications, the annuloplasty structure includes a partialannuloplasty ring.

For some applications, the apparatus further includes acontraction-restricting element configured to be coupled to the secondportion of the coiled element, and the second portion is configured tobe flexible and less longitudinally compressible than the first portionat least in part by virtue of the contraction-restricting element beingcoupled thereto.

For some applications, the contraction-restricting element includes anelement selected from the group consisting of: a suture, a staple, aratchet mechanism, and a bracket.

For some applications, a total length of the first portion includes lessthan 50% of a resting length of the coiled element.

For some applications, a total length of the first portion includes lessthan 30% of a resting length of the coiled element.

For some applications, the valve includes a native mitral valve of thesubject, and the structure is configured for implantation along thenative mitral valve in a manner in which at least the second portion ofthe implant structure is disposed along a portion of the annulus at aposterior leaflet of the valve.

For some applications, the second portion is configured to restrictcontraction of the second portion while facilitating radial movement ofthe second portion of the implant structure.

For some applications,

the atrioventricular valve includes a mitral valve,

the coiled element includes a plurality of second portions, and

the annuloplasty structure is configured for implantation along theannulus in a manner in which:

-   -   a first one of the second portions is configured to be coupled        to the annulus in a vicinity of a left trigone adjacent to the        mitral valve, and    -   a second one of the second portions is configured to be coupled        to the annulus in a vicinity of a right trigone adjacent to the        mitral valve.

For some applications, the combined length of the first and second ofthe second portions is 10-50 mm.

For some applications, the annuloplasty structure is configured forimplantation along the annulus in a manner in which a third one of thesecond portions is disposed along a portion of the annulus at aposterior leaflet of the valve.

For some applications, a length of the third one of the second portionsis 3-120 mm.

For some applications, a length of the third one of the second portionsincludes more than 20% of a resting length of the coiled element.

For some applications, the annuloplasty structure includes:

a sleeve, the sleeve having first and second end portions, respectively,and a body portion that is between the first and second end portions;and

a contracting member that extends along the body portion between thefirst and second end portions of the sleeve, the contracting memberhaving first and second end portions, the first end portion of thecontracting member being coupled to the sleeve in a vicinity of thefirst end portion thereof, and the second end portion of the contractingmember being coupled to the sleeve in a vicinity of the second endportion thereof,

the coiled element being configured to be coupled to the sleeve.

For some applications, the annuloplasty structure has a length ofbetween 50 mm and 150 mm.

For some applications, the annuloplasty structure has a diameter ofbetween 1 mm and 10 mm.

For some applications, the annuloplasty structure is configured to beimplanted along an annulus of a mitral valve of the subject in a mannerin which the annuloplasty structure is formed into at least a portion ofan annuloplasty ring.

For some applications, the annuloplasty structure includes a partialannuloplasty ring having first and second free ends, the first end ofthe sleeve defining the first free end of the partial annuloplasty ring,and the second end of the sleeve defining the second free end of thepartial annuloplasty ring.

For some applications, the coiled element includes a shape-memorymaterial configured to be generally straightened from a coiled stateduring delivery of the annuloplasty structure to an implantation site ofa body of the subject.

For some applications, the sleeve defines a lumen, and the coiledelement includes an elongate coiled element disposed within the lumen ofthe sleeve.

For some applications, the coiled element includes an elongate coiledelement that is configured to be coupled to a portion of an outersurface of the sleeve and rest alongside the portion of the outersurface of the sleeve.

There is additionally provided, in accordance with some applications ofthe present invention, apparatus, including:

an implant structure that is contractible at least in part, the implantstructure including a sleeve, the sleeve having first and second endportions, respectively, and a body portion that is between the first andsecond end portions;

a contracting member that extends along the body portion between thefirst and second end portions of the sleeve, the contracting memberhaving first and second end portions, the first end portion of thecontracting member being coupled to the sleeve in a vicinity of thefirst end portion thereof, and the second end portion of the contractingmember being coupled to the sleeve in a vicinity of the second endportion thereof; and

at least one contraction-restricting element that is coupled to thesleeve and configured to restrict contraction of acontraction-restricted portion of the implant structure duringcontraction of a remaining portion of the implant structure by thecontracting member,

the one or more contraction-restricting elements being coupled to thefirst end portion of the contracting member and disposed along theimplant structure at a distance of between 3 and 45 mm from the firstend of the sleeve,

the contraction-restricting element being configured to restrictcontraction of the contraction-restricted portion of the implantstructure during contraction of a remaining portion of the implantstructure by the contracting member.

For some applications, the implant is configured for implantation alonga native annulus of a native atrioventricular valve of a patient in amanner in which at least the contraction-restricted portion of theimplant structure is disposed along a portion of the annulus in avicinity of a trigone of the valve, and the contraction-restrictionelement is coupled to the contraction-restricted portion.

For some applications, the apparatus further includes a contractingmechanism coupled to the implant structure and configured to contract atleast a contraction-facilitated portion of the implant structure.

For some applications, the contracting mechanism is disposed at a firstportion of the implant structure, and the contracting member extendsalong the implant structure toward the second end of the sleeve.

There is additionally provided, in accordance with some applications ofthe present invention, a method, including:

positioning an annuloplasty structure along an annulus of anatrioventricular valve of a subject, the implant structure including asleeve;

fastening the annuloplasty structure to the annulus;

while the annuloplasty structure is in a fastened state with respect tothe annulus, coupling at least one contraction-restricting element to atleast one contraction-restricted portion of the annuloplasty structure;and

subsequently, contracting at least one contraction-facilitated portionof the annuloplasty structure, the contraction-restricting elementrestricting contraction of the contraction-restricted portion during thecontracting.

For some applications, coupling the contraction-restricting element tothe contraction-restricted portion of the annuloplasty structureincludes coupling the contraction-restricting element to a portion ofthe annuloplasty structure disposed along a portion of the annulus at aposterior leaflet of the valve.

For some applications, coupling the contraction-restricting element tothe contraction-restricted portion of the annuloplasty structureincludes coupling the contraction-restricting element to an outersurface of the annuloplasty structure.

For some applications, coupling the contraction-restricting element tothe contraction-restricted portion of the annuloplasty structureincludes restricting contraction of the contraction-restricted portionof the annuloplasty structure while facilitating radial movement of thecontraction-restricted portion of the annuloplasty structure.

For some applications, positioning the annuloplasty structure along theannulus of the atrioventricular valve includes positioning theannuloplasty structure in a manner in which the contraction-restrictedportion of the annuloplasty structure is disposed along a portion of theannulus at a posterior leaflet of the valve, and coupling thecontraction-restricting element to the contraction-restricted portion ofthe annuloplasty structure includes restricting contraction of thecontraction-restricted portion of the annulus at the posterior leafletof the valve.

For some applications, coupling the contraction-restricting element tothe contraction-restricted portion of the annuloplasty structureincludes advancing into at least a portion of a lumen of the sleeve ofthe annuloplasty structure, a segment having at least a portion thereofthat is non-compressible along a longitudinal axis of the segment.

For some applications, advancing the segment into the portion of thelumen of the sleeve includes advancing a segment that is disposedadjacently to one or more portions that are compressible along thelongitudinal axis of the segment.

For some applications, advancing the segment into the portion of thelumen of the sleeve includes restricting contraction of thecontraction-restricted of the annuloplasty structure while facilitatingradial movement of the contraction-restricted portion of theannuloplasty structure.

For some applications, advancing the segment into the portion of thelumen of the sleeve includes advancing a coiled segment into the portionof the sleeve.

For some applications, the method further includes, prior to advancingthe coiled segment within the sleeve, advancing the coiled segmenttoward the sleeve in a generally straightened configuration, andadvancing the coiled segment into the portion of the sleeve includesallowing the segment to form a coil within the sleeve.

For some applications, fastening the annuloplasty structure to theannulus includes:

removably positioning a deployment manipulator tube through the openingand at least partially within the lumen of the sleeve of theannuloplasty structure, such that the deployment manipulator tubeextends out of the at least one end of the sleeve; and

driving one or more tissue anchors through a wall of the sleeve fromwithin the lumen of the sleeve.

For some applications:

driving the one or more anchors includes advancing through thedeployment manipulator tube an anchor driver that is reversiblycouplable to the one or more anchors,

exposing a distal end of the anchor driver from within a distal end ofthe deployment manipulator tube; and

deflecting through the sleeve the distal end of the anchor driver.

For some applications, the method further includes maintaining relativepositioning of the annuloplasty structure relative to the manipulatortube during the deflecting by applying a force to one or more stiffeningelements that are threaded through the sleeve of the annuloplastystructure.

For some applications, coupling the contraction-restricting element tothe contraction-restricted portion includes coupling thecontraction-restricting element to a portion of the annuloplastystructure that is between 3 and 45 mm from at least one end of thesleeve, while facilitating contraction of the contraction-facilitatedportion of the annuloplasty structure.

For some applications:

the at least one end of the sleeve defines a first free end of theannuloplasty structure,

the annuloplasty structure defines a second free end, and

fastening the annuloplasty structure to the annulus includes:

-   -   fastening the first free end of the of the annuloplasty        structure to the portion of the atrial wall by fastening the        contraction-restricted portion of the annuloplasty structure to        the portion of the atrial wall,    -   fastening the contraction-facilitated portion of the        annuloplasty to a posterior portion of the annulus between the        first and second trigones, and

contracting the first portion of the annuloplasty structure includescontracting the contraction-facilitated portion of the annuloplastystructure that is between the first and second trigones.

For some applications:

the at least one end of the sleeve defines a first free end of theannuloplasty structure,

the annuloplasty structure defines a second free end, and

fastening the annuloplasty structure to the annulus includes:

-   -   fastening the annuloplasty structure to a first trigone of the        valve by fastening the annuloplasty structure to the valve in a        vicinity of the first free end; and    -   fastening the annuloplasty structure to a second trigone of the        valve by fastening the annuloplasty structure to the valve in a        vicinity of the second free end.

For some applications:

fastening the annuloplasty structure to the first trigone includesfastening the first free end of the of the annuloplasty structure to thefirst trigone,

fastening the annuloplasty structure to the second trigone includesfastening the second free end of the of the annuloplasty structure tothe second trigone,

fastening the annuloplasty structure to the annulus includes fasteningthe entire annuloplasty structure along the annulus between the firstand second trigones, and

contracting the contraction-facilitated portion of the annuloplastystructure includes contracting a portion of the annuloplasty structurethat is between the second end and the contraction-restricted portion ofthe annuloplasty structure.

For some applications:

fastening the annuloplasty structure to the first trigone includes:

-   -   fastening the first free end of the of the annuloplasty        structure to a portion of an atrial wall of a heart of the        subject, and    -   fastening a portion of the annuloplasty structure that is        adjacent to the first free end to the first trigone, and

fastening the annuloplasty structure to the second trigone includesfastening the second free end of the of the annuloplasty structure tothe second trigone.

For some applications:

the atrioventricular valve includes a mitral valve;

the annuloplasty structure is shaped so as to define a first end and asecond end, and

positioning the annuloplasty structure along the annulus includes:

-   -   positioning the first end of the annuloplasty structure at a        first trigone of the mitral valve; and    -   positioning the second end of the annuloplasty structure at a        second trigone of the mitral valve.

For some applications, contracting the first portion of the annuloplastystructure includes drawing the first and second ends of the annuloplastystructure toward one another.

For some applications, fastening includes:

anchoring a first location of annuloplasty structure to a first trigoneof the valve; and

anchoring a second location of the annuloplasty structure to a secondtrigone of the valve.

For some applications, anchoring the first location includes anchoring afirst free end of the annuloplasty structure to the first trigone, andanchoring the second location includes anchoring a second free end ofthe annuloplasty structure to the second trigone.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an implant structure comprising asleeve having at least one end flap and a contracting mechanism, inaccordance with some applications of the present invention;

FIG. 2 is a schematic illustration of an anchor deployment manipulatorthat facilitates deployment of one or more anchors through the sleeve ofthe implant structure of FIG. 1, in accordance with some applications ofthe present invention;

FIGS. 3A-3C are schematic illustrations of the anchor deploymentmanipulator of FIG. 2 advancing and deploying anchors from within thesleeve of the implant structure of FIG. 1, in accordance with someapplications of the present invention;

FIGS. 3D-E are schematic illustrations of the closing of the end flap ofthe implant structure following the anchoring of the structure to theannulus, in accordance with some applications of the present invention;

FIG. 3F shows contraction of at least part of the implant structure, inaccordance with some applications of the present invention;

FIG. 4 is a schematic illustration showing a portion of the implantstructure being coupled to a portion of an atrial wall of a heart of apatient; in accordance with some applications of the present invention;

FIG. 5 is schematic cross-sectional illustration of a rotation toolbeing used to rotate a spool of a contracting mechanism of the implantstructure of FIG. 1, in accordance with some applications of the presentinvention;

FIGS. 6A-B show individual components of a contracting mechanism, inaccordance with some applications of the present invention;

FIG. 7 is another cross-sectional illustration of the contractingmechanism of FIG. 5, in accordance with some applications of the presentinvention;

FIGS. 8A-C are schematic illustrations of a procedure for implanting theimplant structure of FIG. 1 to treat a mitral valve, in accordance withsome applications of the present invention;

FIG. 9 is a schematic illustration of the deployment of one of thetissue anchors into cardiac tissue, in accordance with some applicationsof the present invention;

FIGS. 10A-E are schematic illustrations of coupling of acontraction-restricting element to an implant structure configured totreat the mitral valve, in accordance with some applications of thepresent invention;

FIGS. 11A-D are schematic illustrations of coupling of acontraction-restricting element to the implant structure of FIGS. 10A-E,in accordance with another application of the present invention;

FIG. 12 is a schematic illustration of an implant structure configuredto treat the mitral valve coupled to a contraction-restricting element,in accordance with some applications of the present invention;

FIG. 13 is a schematic illustration of an implant structure, inaccordance with some applications of the present invention;

FIGS. 14A-B are schematic illustrations of an implant structurecomprising a sleeve having at least one opening and a closure mechanismfor the opening, in accordance with some applications of the presentinvention; and

FIGS. 15A-C are schematic illustrations of an anchor, in accordance withsome applications of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS

FIGS. 1 and 2 are schematic illustrations of a system 20 for repairing adilated atrioventricular valve, such as a mitral valve, in accordancewith some applications of the present invention. System 20 comprises anadjustable implant structure 22, shown alone in FIG. 1 in anon-contracted state, and an anchor deployment manipulator 60, shownalone in FIG. 2. For some applications, implant structure 22 comprisesan annuloplasty ring, e.g., a partial annuloplasty ring. Implantstructure 22 comprises a flexible sleeve 26. At least a distal portionof anchor deployment manipulator 60 is advanceable within sleeve 26, asshown hereinbelow, and, from within the sleeve, deploys a plurality oftissue anchors through a wall of the sleeve into cardiac tissue, therebyanchoring or otherwise fastening implant structure 22 around at least aportion of the valve annulus. Typically, sleeve 26 has a length ofbetween 50 mm and 150 mm (e.g., between 70 mm and 120 mm), and adiameter of between 1 mm and 10 mm (e.g., between 2.5 mm and 3.5 mm).

Sleeve 26 is typically configured to be placed only partially around thevalve annulus (i.e., to assume a C-shape), and, once anchored in place,to be contracted so as to circumferentially tighten the valve annulus.Alternatively, implant structure 22 is configured to be placed entirelyaround the valve annulus. In order to tighten the annulus, implantstructure 22 comprises a contracting mechanism 40 that actuates aflexible elongated contracting member 30 which extends along implantstructure 22. As shown, contracting member 30 is threaded one or moretimes through sleeve 26. For applications in which implant structure 22comprises a partial annuloplasty ring as shown, sleeve 26 comprisesfirst and second free ends 49 and 51, respectively (i.e., proximal anddistal ends 49 and 51, respectively). First free end 49 is shaped so asto define an opening 25 for passage therethrough of manipulator 60 intoa lumen of sleeve 26. First free end 49 is shaped so as to provide afirst end flap 27 which is coupled to (e.g., by being looped through) aportion of contracting member 30. When contracting mechanism 40 isactuated, contracting member 30 is pulled or released in order to closeor open flap 27 over opening 25. Thus, implant structure 22 comprises aclosure element (e.g., closure mechanism 290) for closing opening 25.For such an application, closure mechanism 290 comprises flap 27 and theportion of contracting member 30 coupled thereto. Typically, closuremechanism 290 is remotely-controlled by the operating physician.

(In this context, in the specification and in the claims, “proximal”means closer to the orifice through which system 20 is originally placedinto the body of the patient, and “distal” means further from thisorifice.)

Following the closing of flap 27 over opening 25, contracting mechanism40 facilitates contracting of implant structure 22. Contractingmechanism 40 is described in more detail hereinbelow. In addition,system 20 comprises a plurality of tissue anchors, typically betweenabout 5 and about 20 anchors, such as about 10 or about 16 anchors. Theanchors are configured to be deployed through the wall of sleeve 26 byanchor deployment manipulator 60. The insertion of the anchors into thesleeve and deployment of the anchors into cardiac tissue is described indetail hereinbelow.

It is noted that although closure element is shown in FIG. 1 asincluding closure mechanism 290, the scope of the present inventionincludes using other closure elements for closing opening 25. Forexample, a plug (such as a silicone plug) may be used to close theopening. Or, an elastomeric band (such as a silicone band) may beconfigured to automatically close the opening, upon removal of themanipulator therefrom. Or, flap 27 may be folded over and an anchor(e.g., a tissue anchor 38, as described herein) may be used to anchorthe folded-over flap to the patient's tissue.

Typically, the closure elements described herein reduce the likelihoodof a thrombosis forming inside sleeve 26, by closing opening 25,relative to if opening 25 were left opened. Alternatively oradditionally, the closure elements described herein are used to closeopening 25 for a different reason.

Typically, the closure of opening 25 (e.g., using the closure elementsdescribed herein) and the deployment of implant structure 22 isperformed during a single procedure, e.g., by deploying the implantstructure and closing opening 25 via a single catheter. For someapplications (not shown), sleeve 26 defines openings 25 at first andsecond ends thereof, and closure elements are used to close the openingsat the first and second ends of the sleeve.

Flexible sleeve 26 may comprise a braided, knitted, or woven mesh or atubular structure comprising ePTFE. For some applications, the braidcomprises metal and fabric fibers. The metal fibers, which may compriseNitinol for example, may help define the shape of the sleeve, e.g., holdthe sleeve open to provide space for passage and manipulation ofdeployment manipulator 60 within the sleeve. The fabric fibers maypromote tissue growth into the braid. Optionally, the sleeve is somewhatelastic, which gives the sleeve a tendency to longitudinally contract,thereby helping tighten the sleeve. For example, the sleeve may bebellows-shaped or accordion-shaped.

Reference is now made to FIGS. 1, 2, 8A-C and 9, which are schematicillustrations of a procedure for implanting implant structure 22 torepair a mitral valve, in accordance with some applications of thepresent invention. Typically, the sleeve is configured to have atendency to assume a straight shape. This straightness helps the surgeonlocate the next site for each subsequent anchor during the implantationprocedure, as described hereinbelow with reference to FIGS. 8A-C. Forexample, because sleeve 26 assumes a generally straight shape, thesleeve may help provide an indication of distance between adjacentanchoring sites.

As shown, sleeve 26 is configured to have a controllably variablestiffness. For example, one or more generally stiff stiffening elements36 (shown in FIG. 1), e.g., a wire or a suture, is threaded one or moretimes (e.g., a plurality of times) through sleeve 26 to provide thestiffness, and subsequently be removed at the conclusion of theimplantation procedure when the stiffness is no longer useful, as isdescribed hereinbelow. Since manipulator 60 and components that areslidable therein are deflectable and steerable, stiffening element 36helps maintain the relative positioning of manipulator 60 with respectto sleeve 26 in order to prevent manipulator 60 from deploying an anchorthrough sleeve 26 in a vicinity of contracting member 30. That is,stiffening element 36 helps maintain the shape and integrity ofstructure 26 (i.e., prevents flailing of sleeve 26). For someapplications, element 36 is pulled directly by an operating physician.For other applications, element 36 is coupled to a portion ofmanipulator 60 or a component that is slidable within a lumen ofmanipulator 60, and is pulled either by the manipulator or any componentthereof. Stiffening element 36 helps ensure that the anchors aredeployed through sleeve 26 without interfering with contracting member30.

Elongated contracting member 30 comprises a wire, a ribbon, a rope, or aband, which typically comprises a flexible and/or superelastic material,e.g., nitinol, polyester, stainless steel, or cobalt chrome. For someapplications, the wire comprises a radiopaque material. For someapplications, contracting member 30 comprises a braided polyester suture(e.g., Ticron). For some applications, contracting member 30 is coatedwith polytetrafluoroethylene (PTFE). For some applications, contractingmember 30 comprises a plurality of wires that are intertwined to form arope structure.

By being threaded or sewn through sleeve 26, contracting member 30 ispositioned at least partially within a lumen of the sleeve 26alternatingly inside and outside of the sleeve along the length of thesleeve. Optionally, sleeve 26 defines an internal channel within whichmember 30 is positioned (configuration not shown). Alternatively, thecontracting member is disposed outside the lumen of the sleeve, such asalongside an outer wall of the sleeve. For example, sleeve 26 may definean external channel within which member 30 is positioned, or the sleevemay comprise or be shaped so as to define external coupling elements,such as loops or rings (configuration not shown). For some applications,contracting member 30 is positioned approximately opposite the portionof sleeve 26 through which the anchors are deployed, as describedhereinabove.

For some applications of the present invention, contracting mechanism 40comprises a rotatable structure, such as a spool. The rotatablestructure is arranged such that rotation thereof contracts implantstructure 22. For some applications, a first end portion of contractingmember 30 is coupled to the spool (e.g., by being looped through aportion of the spool). For some applications, contracting mechanism 40further comprises a housing 44 that houses the rotatable structure,e.g., the spool. A braided fabric mesh 41 surrounds housing 44 so as tofacilitate implantation thereof and induce fibrosis around housing 44.The spool is positioned in a vicinity of (e.g., within 1 cm of) end 51of sleeve 26, as shown. As shown, a second end portion of contractingmember 30 is coupled to sleeve 26 in a vicinity of (e.g., within 0.5 cmof) end 49 of the sleeve 26, opposite end 51 to which the contractingmechanism 40 is positioned. Typically, contracting mechanism 40 issutured to sleeve 26 by coupling threads 31.

In the configuration shown, the second end portion of contracting member30 is looped through a portion of flap 27 and extends back toward end 51of sleeve 26. The second end portion of contracting member 30 is coupledto sleeve 26 in a vicinity of first end 49 of the sleeve at a distanceof between 0.2 cm and 2 cm from end 49. Since contracting member 30 islooped through a portion of contracting mechanism 40, the free ends ofcontracting member 30 are brought together, and together serve as thesecond end portion of contracting member 30. Alternatively, contractingmember 30 is not looped through a portion of contracting mechanism 40, afirst end of contracting member 30 is fixedly coupled to contractingmechanism 40, while a second end of contracting member 30 defines thesecond end portion that is coupled to the portion of sleeve 26.

The second end portion of member 30 is coupled to sleeve 26 bycontraction-restricting elements 200, e.g., crimping elements 32 and 34.Crimping elements 32 and 34 restrict contraction of acontraction-restricted portion 52 of sleeve 26 that has a length ofbetween 5 mm and 30 mm. For some applications, the crimping elements aredisposed such that the contraction-restricted portion of the sleeve isbetween 3 and 45 mm from one end of the sleeve. The remaining portion ofsleeve 26, i.e., a contraction-facilitated portion 53 is contractibleand expandable in response to respective tightening or loosening ofcontracting member 30 responsively to the actuation of contractingmechanism 40. Thus, while contraction of implant structure 22 is beingongoing (i.e., while contraction-facilitated portion 53 is beingcontracted), contraction-restricted portion 52 is restricted from beingcontracted. For some applications, contraction-restriction portions,each having a length of between 5 mm and 30 mm are disposed, aredisposed in the vicinity of both ends of sleeve 26.

Rotation of the spool of contracting mechanism 40 in a first rotationaldirection winds a portion of contracting member 30 around the spool,thereby pulling the far end of implant structure 22 toward the spool andshortening and tightening implant structure 22.

Alternatively, in some configurations, contracting mechanism 40 ispositioned at an intermediary position along the sleeve, rather than ina vicinity of one of the ends. For these configurations, contractingmember 30 comprises two contracting members, which are respectivelyconnected to the two ends of the sleeve, and both of which are connectedto the spool. Rotating the spool contracts both contracting members.These configurations may be implemented using techniques described inU.S. patent application Ser. No. 12/341,960 to Cabiri (published as US2010/0161047), which is incorporated herein by reference, with referenceto FIG. 15 thereof.

For other applications, contracting member 30 comprises at least onewire (e.g., exactly one wire) that passes through a coupling mechanismof the spool of contracting mechanism 40, in order to couple the wire tothe spool. As described hereinabove, the free ends of contracting member30 are brought together, and together serve as the second end portion ofcontracting member 30, and may be coupled to one of the severallocations of sleeve 26 mentioned hereinabove. In this configuration,approximately the longitudinal center of the wire serves as first end ofthe contracting member.

FIG. 2 shows manipulator 60 comprising an elongate outer tube 62(sometimes referred to herein, including in the claims, as a “deploymentmanipulator tube”) having a tube lumen and a distal end 64 which definesan opening for passage therethrough of the one or more anchors.Typically, the one or more anchors are coupled to an anchor driver (asdescribed hereinbelow) which slides through the lumen of manipulator 60.A proximal pushing tube 33 slides along tube 62 of manipulator 60. Adistal end of pushing tube 33 is coupled to a coupler 39 which increasesfriction at a distal end of pushing tube 33 so as to facilitate asliding of pushing tube 33 along tube 62 of manipulator 60, whiletemporarily maintaining the distal end of pushing tube 33 in place withrespect to tube 62 of manipulator 60. Coupler 39 comprises one or more(e.g., two, as shown) coupling elements 29 which are configured toremovably couple the distal end of pushing tube 33 to proximal end 49 ofsleeve 26, as described hereinbelow. Coupling elements 29 hold sleeve 26surrounding deployment manipulator 60.

FIGS. 3A-C are schematic illustrations of manipulator advanced into alumen of sleeve 26 of implant structure 22 in order to deploy one ormore tissue anchors 38, in accordance with some applications of thepresent invention. Anchor deployment manipulator 60 is advanced into alumen of sleeve 26, and, from within the lumen, deploys anchors 38through a wall of the sleeve and into cardiac tissue, thereby anchoringthe sleeve around a portion of the valve annulus. Typically, implantstructure 22 and anchor deployment manipulator 60 are introduced intothe heart via a sheath 104, as described hereinbelow with reference toFIGS. 8A-C.

As shown in FIG. 3B, an anchor driver 68 is slidable within a lumen oftube 62 of manipulator 60. Anchor driver 68 is coupled at a distal endthereof to a driving interface 69 that is either male (e.g., comprisinga screwdriver head, having, such as a slot-head, an Allen-head, aPhillips-head, a Robertson-head, or a hex-head) or female (e.g.,comprising a wrench head, having, for example, a square or hex opening),as appropriate for the driving interface provided. Anchor driver 68 issteerable and deflectable independently of the steerability anddeflectability of tube 62 of manipulator 60.

For some applications, at least one of anchors 38 is deployed from adistal end 64 of deployment manipulator 60 while the distal end ispositioned such that a central longitudinal axis 62 through distal end60 of deployment manipulator 60 forms an angle of between about 45 and90 degrees with the wall of sleeve 26 at the point at which the anchorpenetrates the wall, such as between about 75 and 90 degrees, e.g.,about 90 degrees (as shown hereinbelow with reference to FIGS. 8A-C).For other applications, as shown in FIG. 3B, at least one of anchors 38is deployed from driving interface 69 while interface 69 is positionedsuch that a central longitudinal axis through the distal end ofinterface 69 forms an angle of between about 45 and 135 degrees with thewall of sleeve 26 at the point at which the anchor penetrates the wall,such as between about 75 and 100 degrees, e.g., about 90 degrees. Thus,manipulator 60 has steerability and anchor driver 68 has steerabilitythat is independent from the steerability of manipulator 60. For someapplications of the present invention, the steerability of manipulator60 is in a different plane than the steerability of anchor driver 68.

This anchor-penetration point is typically at a portion of the sleevethat extends distally beyond distal end 64 of deployment manipulator 60.Typically, all of the anchors are deployed at such angles, with thepossible exception of the first anchor deployed near the distal end ofthe sleeve.

Reference is now made to FIG. 3B. As shown, deployment manipulator 60comprises outer tube 62 and anchor driver 68 which is at least partiallypositioned within tube 62. Anchor driver 68 comprises an elongated,flexible shaft 70, having at its distal end a driver head 72. Rotationof anchor driver 68 screws anchors 38 into the cardiac tissue. Each ofanchors 38 is shaped so as to define a coupling head 74 and a tissuecoupling element 76. The anchors are typically rigid. Tissue couplingelements 76 may, for example, be helical or spiral in shape (e.g.,having the shape of a corkscrew), as shown in the figures, may comprisescrews, or may have other shapes. Coupling heads 74 may be either male(e.g., a hex or square protrusion) or female (e.g., a straight slot, ahex opening, a Phillips opening, or a Robertson opening). The use ofhelical anchors, which are screwed into the cardiac tissue, generallyminimizes the force that needs to be applied during deployment of theanchors into the cardiac tissue. Alternatively, the anchors may comprisestaples, clips, spring-loaded anchors, or other tissue anchors describedin the references incorporated hereinabove in the Background section, orotherwise known in the art.

For some applications, outer tube 62 of deployment manipulator 60 issteerable, as known in the catheter art. To provide steeringfunctionality to deployment manipulator 60, outer tube 62 typicallycomprises one or more steering wires, the pulling and releasing of whichcause deflection of the distal tip of the tube.

For some applications of the present invention, each of tissue couplingelements 76 is shaped so as to define a longitudinal axis 78 (shown inFIG. 3B), and is configured to penetrate the cardiac tissue in adirection parallel to longitudinal axis 78. Deployment manipulator 60 isconfigured to deploy tissue coupling element 76 from distal end 64 ofthe deployment manipulator through the wall of sleeve 26 in a directionparallel to longitudinal axis 78 and parallel to a central longitudinalaxis 65 through distal end 64 of deployment manipulator 60 (axis 65 isshown hereinbelow in FIG. 9).

For some applications, the plurality of anchors are applied using thedeployment manipulator by loading a first one of the anchors onto theanchor driver, and deploying the anchor into the cardiac tissue. Theanchor driver is withdrawn from the patient's body (typically whileleaving outer tube 62 of the deployment manipulator in place in thesleeve), and a second one of the anchors is loaded onto the anchordriver. The anchor driver is reintroduced into the outer tube of thedeployment manipulator, and the second anchor is deployed. These stepsare repeated until all of the anchors have been deployed. Alternatively,the entire deployment manipulator, including the anchor driver, isremoved from the body and subsequently reintroduced after being providedwith another anchor. Techniques for use with the refillable deploymentmanipulator may be practiced in combination with techniques described inU.S. patent application Ser. No. 12/689,635 to Zipory et al. (publishedas US 2010/0280604), entitled, “Over-wire rotation tool,” filed Jan. 19,2010, which is incorporated herein by reference, and with techniquesdescribed in PCT Patent Application PCT/IL2010/000358 to Zipory et al.(published as WO 10/128503), entitled, “Deployment techniques forannuloplasty ring,” filed May 4, 2010, which is incorporated herein byreference. Further alternatively, the deployment manipulator isconfigured to simultaneously hold a plurality of anchors, and to deploythem one at a time.

Reference is again made to FIGS. 3A-C. FIG. 3A shows the slidableadvancement of manipulator 60 through the lumen of sleeve 26 of implantstructure 22. Manipulator 60 slides proximally from distal end 51 ofsleeve 26 in order to facilitate implantation of anchors 38 withincardiac tissue of the patient. As shown in FIG. 3B, a first tissueanchor 38 is implanted in a vicinity of end 51 (e.g., at end 51 asshown). Anchor 38 is implanted when anchor driver 68 is rotated in orderto corkscrew anchor 38 into the tissue. Following the anchoring ofanchor 38 in the vicinity of end 51, manipulator 60 is withdrawnproximally so as to anchor a second anchor 38 into cardiac tissue.

Typically, the first anchor 38 is deployed most distally in sleeve 26(generally at or within a few millimeters of end 51 of sleeve 26), andeach subsequent anchor is deployed more proximally, such that sleeve 26is gradually pulled off (i.e., withdrawn from) deployment manipulator 60in a distal direction during the anchoring procedure. Typically, as thesleeve is pulled off the deployment manipulator, the deploymentmanipulator is moved generally laterally along the cardiac tissue, asshown in FIGS. 3B-C.

The pushing of sleeve 26 distally from manipulator 60 is facilitated bypushing tube 33. Pushing tube 33 passes over outer tube 62 ofmanipulator 60, and pushes gently in a distal direction on proximal end49 of sleeve 26. The pusher tube is held in place against proximal end49 of sleeve 26, typically by an external control handle (not shown forclarity of illustration) that is coupled to respective proximal ends ofmanipulator 60, tube 62, anchor driver 68, and pushing tube 33. Assleeve 26 is pulled off (i.e., withdrawn from) outer tube 62 ofdeployment manipulator 60, pushing tube 33 pushes sleeve 26 distallywith respect to outer tube 62, helping withdraw the sleeve from theouter tube. If the pusher tube were not provided, the wall of sleeve 26might snag on outer tube 62 (as mentioned above, the sleeve may comprisebraided or woven fabric). In addition, if such snagging occurs, gentlepushing with the pusher tube in the distal direction may help free thesnag.

In the configuration shown in FIG. 3A, pushing tube 33 comprises one ormore coupling elements 29 (such as exactly one coupling element orexactly two coupling elements) at a distal end of tube 38. Couplingelements 29 are configured to removably couple proximal end 49 of sleeve26 to the distal end of pushing tube 33, thereby allowing sleeve 26 frommoving distally with respect to outer tube 62 of deployment manipulator60 only to the extent that pushing tube 33 is released in the distaldirection (as indicated by the downward arrow in FIG. 3B), such as usingthe external control handle, while manipulator 60 is pulled proximally.Alternatively, both pushing tube 33 and manipulator are pulledproximally (e.g., by pulling proximally the external control handle) andpushing tube 33 thereby applies a passive counter force in order toresist proximal end 49 of sleeve 26 in a manner in which, responsivelyto the passive force, proximal end 49 of sleeve 26 is advanced distally.

For some applications, coupling elements 29 have a natural tendency toflex inwards (toward a central longitudinal axis of sleeve 26 thatpasses through the proximal end of the sleeve). Outer tube 62, whenpositioned within the sleeve in a vicinity of the coupling elements,pushes the coupling elements outwards (away from the centrallongitudinal axis), causing the coupling elements to engage the sleeve.For example, the coupling elements may be curved to defineoutwardly-directed ends that push against or pierce the sleeve. Suchpushing against or piercing engages the sleeve, which, as mentionedabove, may comprise braided or woven fabric.

During the anchoring procedure, stiffening element 36 maintains relativedispositions of manipulator and/or anchor driver 68 with respect tosleeve 26. As shown, stiffening element 36 is threaded along sleeve 26.The relative stiffness of stiffening element to the flexibility ofsleeve 26 maintains sleeve 26 in a relative spatial configuration inwhich contracting member 30 remains above tube 62 of manipulator 60and/or anchor driver 68. In such a manner, stiffening element 36 helpsensure that anchors 38 do not interfere with contracting member 30 andthat the portion of sleeve 26 that is opposite contracting member 30 isanchored to the annulus. Stiffening element 36 is loosely coupled (i.e.,is not fixed by being knotted or otherwise fastened) to a distal end 35thereof (shown in FIG. 3A) to a distal portion of sleeve 26 in avicinity of end 51 of sleeve 26. A proximal end of stiffening element 36is coupled to a coupler 37 (or a ring) which is coupled to pushing tube33. As sleeve 26 is slid gradually distally from outer tube 62 ofmanipulator 60, as described hereinabove, since coupler 37 is fixed topushing tube 33, the successive distal portions of stiffening element 36are decoupled, by being unthreaded, from sleeve 26 responsively to thedistal sliding of sleeve 26 from tube 62 of manipulator 60.

FIG. 3C shows anchoring of an additional tissue anchor 38 to the annulusof the valve. As described hereinabove, with each successive anchor 38that is deployed, successive portions of sleeve 26 are slid of tube 62of manipulator 60. For some applications, portions of stiffening element36 are unthreaded from sleeve 26.

Following the anchoring of sleeve 26 by anchoring a suitable number ofanchors around a desired portion of the annulus of the valve, sleeve 26is slid off of manipulator 60 and decoupled from coupling elements 29 inorder to release sleeve 26 from coupling elements 29. Proximalwithdrawal of outer tube 62 from sleeve 26 (into or through pushing tube33) allows coupling elements 29 to assume their natural inwardly-flexedposition, thereby releasing sleeve 26 from the coupling elements, anddecoupling the sleeve from the pusher tube. As described hereinabove,sleeve 26 is gradually pulled off (i.e., withdrawn from) deploymentmanipulator 60, including outer tube 62, in a distal direction duringthe anchoring procedure. Outer tube 62 of deployment manipulator 60 isproximally withdrawn completely from the sleeve at the conclusion of theanchoring procedure. The flexing of the coupling elements releases thesleeve at the conclusion of the procedure. As pushing tube 33 isdecoupled from sleeve 26 and is withdrawn proximally, pushing tube 33pulls on stiffening element 36 in order to entirely decouple, byunthreading stiffening element 36 from sleeve 26.

Reference is now made to FIG. 3D, which is a schematic illustration ofimplant structure 22 anchored to the annulus of a mitral valve 130 ofthe patient, in accordance with some applications of the presentinvention. A plurality of tissue anchors (e.g., 8 tissue anchors asshown by way of illustration and not limitation) anchor implantstructure 22 to the annulus. As shown, in some applications of thepresent invention, first end 49 of structure 22 is anchored in avicinity of a first trigone 2 (e.g., at first trigone 2) of valve 130 bya first anchor 137, and second end 51 of structure 22 is anchored in avicinity of a second trigone 4 (e.g., at second trigone 4) of valve 130by a second anchor 139. In such an embodiment in which first and secondends 49 and 51 are anchored to the annulus of the valve, bothcontraction-restricted portion 52 of sleeve 26 andcontraction-facilitated portion 53 of sleeve 26 are disposed along aportion of the annulus that is between trigones 2 and 4 and along ajunction of the annulus and a posterior leaflet 14 and portions ofanterior leaflet 12.

In such an application, since contraction-restricted portion 52 isdisposed along the portion of the annulus, only a section of the portionof the annulus (i.e., the section along which contraction-facilitatedportion 53 is disposed) is contracted by implant structure 22. For someapplications, the sleeve defines two contraction-restricted portions 52,as described hereinabove. For such applications, typically uponimplantation of the sleeve at the annulus, the contraction-restrictionportions are disposed in the vicinity of trigones 2 and 4.

FIG. 3D shows implant structure 22 following extraction of manipulator60 from within the lumen of sleeve 26. Immediately following theextraction of manipulator 60, flap 27 of closure mechanism 290 isdisposed in an opened state, as shown. Additionally, implant structure22 is shown in a non-contracted state having an angle α (alpha) betweenrespective longitudinal axes 78 of successive anchors 38, angle α beingbetween 10 degrees and 30 degrees.

As shown in FIGS. 1 and 3A-D, implant structure 22 comprises acontracting mechanism, such as contracting mechanism 40. Contractingmechanism 40 comprises a rotatable structure, arranged such that initialrotation of the rotatable structure in a first rotational direction inorder to pull contracting member 30, closes flap 27 over the opening atend 49 of implant structure 22, and further rotation of the rotatablestructure in the first rotational direction contracts at least a portion(e.g., the entire contraction-facilitated portion 53) of implantstructure 22. It is to be noted that the rotatable structure is capableof being rotated bidirectionally such that following rotation of therotatable structure in the first rotational direction in order tocontract implant structure 22, the rotatable structure may be rotatedinitially in a second rotational direction that is opposite the firstrotational direction, in order slacken contracting member 30 to expandat least a portion (e.g., the entire contraction-facilitated portion 53)of implant structure 22. In response to further rotation of therotatable structure in the second rotational direction, flap 27 isopened. Implant structure 22 further comprises a longitudinal member 86,such as a wire, which is coupled to contracting mechanism 40 and passesout of the body of the patient.

Reference is now made to FIGS. 3E-F, which are schematic illustrationsof a rotation tool 80 used to facilitate contraction of implantstructure 22 by actuating contracting mechanism 40. A tool, such asrotation tool 80, is provided for rotating the rotatable structure. Tool80 is configured to be guided over longitudinal member 86, to engage therotatable structure of contracting mechanism 40, and to rotate therotatable structure in response to a rotational force applied to thetool.

Reference is now made to FIGS. 3D-E. As shown in FIG. 3D, contractingmechanism 40 is shaped so as to provide a driving interface 48 whichfacilitates coupling of rotation tool 80 to the rotatable structure ofcontracting mechanism 40. In order to readily bring the rotation tool todriving interface 48, rotation tool 80 is guided over (as shown in FIG.3E) the longitudinal member, or alongside the longitudinal member(configuration not shown). Alternatively, longitudinal member 86comprises a suture or other highly flexible element. For someapplications, the longitudinal member comprises a tube, through whichrotation tool 80 is passed to bring the tool to the driving interface48. For some applications, longitudinal member 86 has a diameter ofbetween 0.1 and 1 mm, such as 0.4 mm.

For some applications, longitudinal member 86 is looped throughcontracting mechanism 40, and both ends of the longitudinal member arebrought together and extend outside of the patient's body. Thelongitudinal member is decoupled from the contracting mechanism byreleasing one end of the longitudinal member, and pulling on the otherend to draw the longitudinal member away from the contracting mechanism.

For some applications, contracting mechanism 40 is positioned in avicinity of (e.g., within 1 cm of) distal end 51 of sleeve 26, andaccess to driving interface 48 is provided from outside sleeve 26, asshown in FIGS. 3E-F (in which the contracting mechanism is positioned ina vicinity of end 51 of the sleeve).

For some applications in which access to driving interface 48 isprovided from outside sleeve 26, the rotation tool is initiallyremovably attached to the driving interface, prior to the commencementof the implantation procedure, and is subsequently decoupled from thedriving interface after the rotatable structure has been rotated. Inthese applications, contracting mechanism 40 may be positioned in avicinity of distal end 51 or proximal end 49 of sleeve 26, or at anintermediate location along the sleeve. Optionally, at least a portionof a shaft of the rotation tool is positioned within a sheath 89 whichadvances through an access sheath that is disposed within thevasculature of the patient.

FIG. 3E shows implant structure 22 prior to contraction thereof.Contracting mechanism 40 is initially rotated in a first rotationaldirection so as to close flap 27 over the opening at end 49 of implantstructure 22. As shown during the initial pulling of contracting member30 by initial rotation of the rotatable structure of contractingmechanism 40, the angle between respective longitudinal axes 78 ofsuccessive anchors 38 remains angle α (alpha).

In FIG. 3F, contracting mechanism 40 is actuated further by rotationtool 80 in order to contract at least a portion of structure 22 (i.e.,at least a portion or all of contraction-facilitated portion 53 ofstructure 22). As shown, an angle β (beta) between respectivelongitudinal axes 78 of successive anchors 38 of contraction-facilitatedportion 53, angle β being between 5 degrees and 25 degrees, and beingsmaller than angle α (alpha) shown in FIGS. 3D-E. Additionally, as shownin FIG. 3F, sleeve 26 at contraction-facilitated portion 53 is shown asbeing in a contracted state (i.e., wavy, as shown), while sleeve 26 atcontraction-restricted portion 52 is shown in a non-contracted state(i.e., straight, as shown).

Reference is now made to FIG. 4, which is a schematic illustrationshowing a portion of implant structure 22 being coupled to a portion ofan atrial wall 141 of the heart of the patient, in accordance with someapplications of the present invention. For some applications, a portion(e.g., the entire portion) of contraction-restricted portion 52 of isanchored to the portion of atrial wall 141. For such applications, theentire contraction-facilitated portion 53 may be coupled to the annulusof valve 130 along a portion of the annulus that is between trigones 2and 4 and along a junction of the annulus and a posterior leaflet 14 andportions of anterior leaflet 12. In such an application, sincecontraction-restricted portion 52 is not disposed along the portion ofthe annulus, the entire portion of the annulus (i.e., the section alongwhich contraction-facilitated portion 53 is disposed) is contracted byimplant structure 22.

It is to be noted, as shown that first anchor 137 is anchored to theannulus in a vicinity of first trigone 2 (e.g., at first trigone 2), andsecond anchor 139 is anchored to the annulus in a vicinity of secondtrigone 4 (e.g., at second trigone 4).

Reference is now made to FIGS. 3D and 4. It is to be noted that implantstructure 22, shown in either application in FIG. 3D or 4, has the samelength when elongated along a longitudinal axis (i.e., when not formedinto a curved structure, as shown). It is to be noted that anchoringstructure to the annulus of valve 130 using either application as shownin FIG. 3D or 4 depends on the level of distention of valve 130 of agiven patient. That is, for patients having a greater degree ofdistention, the entire structure 22 is coupled to the annulus along theportion thereof that is between first and second trigones 2 and 4,respectively, and along the junction of the annulus and posteriorleaflet 14 and portions of anterior leaflet 12. For patients having alesser degree of distention, excess portions of structure 22 may beanchored to the portion of atrial wall 141. It is to be noted that theportion of atrial wall 141 to which the portion of structure 22 isanchored may be a portion of a free wall of the atrium, as shown, or aportion of the interatrial septum (not shown). Typically,contraction-restricted portion 52 is anchored to the portion of atrialwall 141.

Reference is now made to FIG. 5, which is a schematic cross-sectionalillustration of a configuration of rotation tool 80 being used to rotatethe rotatable structure (e.g., a spool 46, as shown) of contractingmechanism 40 of implant structure 22, in accordance with someapplications of the present invention. In this application, as in theconfigurations shown in FIGS. 1, 3A-F and 4, access to driving interface48 is provided from outside sleeve 26. Contracting mechanism 40comprises longitudinal member 86 that is attached to the contractingmechanism 40 and passes out of the body of the patient. In order toreadily bring rotation tool 80 to driving interface 48, rotation tool 80is guided over longitudinal member 86. In this application, rotationtool 80 comprises one or more tubes that pass over the longitudinalmember, as described below.

As mentioned above, for some applications, longitudinal member 86comprises a wire, which may comprise metal. Because the wire is fairlystiff, the wire generally maintains its direction and orientation withrespect to contracting mechanism 40. The wire thus readily guides thetubes to the contracting mechanism such that the tubes have a desiredorientation and position with respect to the contracting mechanism.

Longitudinal member 86 is removably coupled to contracting mechanism 40,typically to a central portion of an upper surface 50 of spool 46. Forsome applications, a distal portion 88 of longitudinal member 86 isshaped so as to define a screw thread 90 (i.e., a mechanical structurethat is coupled to member 86 at a distal end portion thereof). Distalportion 88 is screwed into a threaded opening 92 of upper surface 50, inorder to removably couple longitudinal member 86 to contractingmechanism 40. Typically, the distal portion is initially coupled to thecontracting mechanism before implant structure 22 is placed into anatrium of the patient. As described below, the distal portion isdecoupled from the contracting mechanism after spool 46 has been rotatedto tighten implant structure 22. For some applications, distal portion88 comprises a discrete element that is fixed to longitudinal member 86,while for other application, distal portion 88 is integral withlongitudinal member 86.

For some applications, rotation tool 80 comprises an inner (first) tube98, an intermediate (second) tube 96, and, optionally, an outer (third)tube 94. Rotation of each of the tubes is independently controlled, suchas using techniques described in U.S. patent application Ser. No.12/689,635 to Zipory et al. (published as US 2010/0280604), entitled,“Over-wire rotation tool,” filed Jan. 19, 2010, which is incorporatedherein by reference. For some applications, a distal portion of each oftubes 94, 96, and 98 that enters the patient's body comprises braidedplastic, and a proximal portion of each of the tubes that does not enterthe patient's body comprises a hard material, such as metal (not shown).For example, the distal and proximal portions may have lengths ofbetween 50 and 100 cm and between 50 and 350 cm, respectively.Distal-most portions 94D, 96D, and 98D, respectively, of the distalportions typically comprise a hard material, such as metal, in order toengage other elements, as described immediately below. Typically, thedistal-most portions comprise separate elements that are coupled totheir respective tubes. For example, the distal-most portions may havelengths of between 1 and 10 mm.

Intermediate tube 96 is configured to rotate spool 46. To this end,intermediate tube 96 (such as distal-most portion 96D thereof) isconfigured to engage upper surface 50 of spool 46. To enable suchengagement, the upper surface typically is shaped so as to define one ormore indentations 99 (e.g., grooves), in which corresponding protrusionsat the distal end of intermediate tube 96 are positioned, such as bygently rotating tube 96 (or all of the tubes) until such engagementoccurs. (Spring may be provided to assist with such engagement.) Theradius of intermediate tube 96 is approximately equal to the distance ofeach of the indentations from a center of upper surface 50, so that theprotrusions at the distal end of the tube are aligned with theindentations. Alternatively, the upper surface defines one or moreprotrusions, which engage indentations on the distal end of tube 96(configuration not shown). Indentations 99 or the protrusions thus serveas driving interface 48.

Rotation of intermediate tube 96 causes corresponding rotation of spool46, thereby winding contracting member 30 around the spool, andtightening the contracting member.

An outer tube 94, if provided, is configured to prevent rotation ofspool housing 44 during rotation of spool 46. To this end, outer tube 94(such as distal-most portion 94D thereof) is configured to engage anupper surface 160 of spool housing 44. To enable such engagement, theupper surface typically is shaped so as to define one or moreindentations 162 (e.g., grooves), in which corresponding protrusions atthe distal end of outer tube 94 are positioned, such as by gentlyrotating the tube (or all of the tubes) until such engagement occurs.(Springs may be provided to assist with such engagement.) The radius ofouter tube 94 is approximately equal to the distance of each of theindentations from a center of spool housing 44, so that the protrusionsat the distal end of the tube are aligned with the indentations.Alternatively, the upper surface defines one or more protrusions, whichengage indentations on the distal end of tube 94 (configuration notshown).

During rotation of intermediate tube 96 for rotating spool 46, outertube 94 is held rotationally stationary, thereby stabilizing spoolhousing 44 and enabling spool 46 to rotate with respect to housing 44either in a first rotational direction or a second rotational directionthat is opposite the first rotational direction. For example, whendistal portion 88 is rotated in the first rotational direction,contracting member 30 is wound around spool 46, and when distal portion88 is rotated in the second rotational direction, contracting member 30is unwound from around spool 46. As described hereinabove, tool 80 isslid within sheath 89.

Inner tube 98 is configured to decouple longitudinal member 86 fromspool 46 after contracting member 30 has been sufficiently wound aroundthe spool, as described above. To this end, a distal portion of theinner tube (such as distal-most portion 98D thereof) is shaped so as toengage a distal portion of longitudinal member 86, which is typicallyshaped so as to couple with the distal portion of the inner tube.

Rotation of inner tube 98, while intermediate tube 96 is prevented fromrotating and thus prevents rotation of spool 46, causes correspondingrotation of longitudinal member 86, and unscrews the longitudinal memberfrom spool 46. Longitudinal member 86 and spool 46 are typicallyconfigured such that this unscrewing rotation is in the oppositedirection of the rotation of the spool that tightens the contractingmember. For example, clockwise rotation of the spool (looking down onthe spool) may wind the contracting member around the spool, whilecounterclockwise rotation of longitudinal member 86 may unscrew thelongitudinal member from the spool. To enable the engagement of innertube 98 with the distal portion of the longitudinal member, the distalportion may include a flat portion.

As shown, spool 46 is shaped to define a driving interface 48. For someapplications, driving interface 48 is female. For example, the interfacemay be shaped to define a channel which extends through the cylindricalportion of spool 46 from an opening provided by an upper surface 178(shown below in FIG. 6A, for example) of spool 46 to an opening providedby a lower surface 180 of spool 46. Alternatively, driving interface 48is shaped so as to define an indentation (e.g., a groove) that does notextend entirely through the cylindrical portion of the spool. Furtheralternatively, driving interface 48 is male, and defines a protrusion,e.g., a hexagonal head or a head having another shape.

For some applications, a distal portion of a rotation tool 80, engagesspool 46 via driving interface 48 and rotates spool 46 in response to arotational force applied to the rotation tool. The rotational forceapplied to the rotation tool rotates spool 46 via the portion of therotation tool that engages driving interface 48 of spool 46.

Spool 46 typically comprises a locking mechanism that prevents rotationof the spool after contracting member 30 has been tightened. Forexample, locking techniques may be used that are described withreference to FIG. 4 of above-mentioned U.S. application Ser. No.12/341,960 to Cabiri (published as US 2010/0161047), and/or withreference to FIGS. 6B, 7, and 8 of U.S. patent application Ser. No.12/689,635 to Zipory et al. (published as US 2010/0280604), entitled,“Over-wire rotation tool,” filed Jan. 19, 2010, which are incorporatedherein by reference.

Alternatively, for some applications, contracting mechanism 40 isconfigured to tighten contracting member 30, crimp the contractingmember to hold the contracting member taut, and subsequently cut theexcess length of the contracting member.

Distal portion 88 of rotation tool 80 has a head that is male (e.g.,comprising a threaded screwdriver head, as shown) having, such as aslot-head, an Allen-head, a Phillips-head, a Robertson-head, or ahex-head. For some applications, distal portion 88 of rotation tool 80has a head that is female (e.g., comprising a wrench head, having, forexample, a square or hex opening), as appropriate for driving interface48 provided. Typically, the rotation tool comprises a shaft (e.g., tube94), at least a portion of which is flexible. For some applications, therotation tool is used that is described in above-referenced U.S. patentapplication Ser. No. 12/341,960 (published as US 2010/0161047), withreference to FIG. 4 thereof.

FIG. 6 shows a relationship among individual components of contractingmechanism 40, in accordance with some applications of the presentinvention. Contracting mechanism 40 is shown as comprising spool housing44 which defines an upper surface 160 and a recessed portion 176. Spool46 is configured to be disposed within housing 44 and defines an uppersurface 178, a lower surface 180 and a cylindrical body portion disposedvertically between surfaces 178 and 180. For some applications, acontracting mechanism as shown in FIG. 6B is used, mutatis mutandis.Although some applications of the present invention are described withreference to a contracting mechanism as shown in FIG. 6A, the scope ofthe present invention includes using the contracting mechanism shown inFIG. 6B in combination with other components of the apparatus describedherein.

Reference is now made to FIGS. 5 and 6A. Lower surface 180 of spool 46is shaped to define one or more (e.g., a plurality, as shown) recesses182 which define structural barrier portions 188 of lower surface 180.It is to be noted that any suitable number of recesses 182 may beprovided, e.g., between 1 and 10 recesses, circumferentially (as shown)or otherwise with respect to lower surface 180 of spool 46.

For some applications, as mentioned above, spool 46 comprises a lockingmechanism 164 (FIG. 5). For some applications, locking mechanism 164 iscoupled, e.g., welded, at least in part to a lower surface of spoolhousing 44. Typically, locking mechanism 164 defines a mechanicalelement having a planar surface that defines slits 184. The surface oflocking mechanism 164 may also be curved, and not planar. Lockingmechanism 164 is shaped to provide a protrusion 166 which projects outof a plane defined by the planar surface of the mechanical element. Theslits define a depressible portion 168 of locking mechanism 164 that isdisposed in communication with and extends toward protrusion 166.Depressible portion 168 is moveable in response to a force appliedthereto by a distal element 70 that extends in a distal direction fromdistal portion 88 of longitudinal member 86, beyond threaded opening 92of upper surface 50, as shown in FIG. 5.

It is to be noted that the planar, mechanical element of lockingmechanism 164 is shown by way of illustration and not limitation andthat any suitable mechanical element having or lacking a planar surfacebut shaped to define at least one protrusion may be used together withlocking mechanism 164.

A cap 170 is provided that is shaped so as to define a planar surfaceand an annular wall having an upper surface 186 that is coupled to,e.g., welded to, a lower surface of spool housing 44. The annular wallof cap 170 is shaped so as to define a recessed portion 172 of cap 170that is in alignment with recessed portion 176 of spool housing 44.

For some applications, spool 46 of contracting mechanism 40 is shaped toprovide a hole 42 or other coupling mechanism for coupling the first endportion of contracting member 30 to the spool, and thereby tocontracting mechanism 40.

Reference is again made to FIG. 5, and is additionally made to FIG. 7,which is another cross-sectional illustration of contracting mechanism40, in accordance with an application of the present invention. FIG. 5shows contracting mechanism 40 in an unlocked state, while FIG. 7 showsthe contracting mechanism in a locked state.

In the unlocked state shown in FIG. 5, protrusion 166 of lockingmechanism 164 is disposed within recessed portion 172 of cap 170.Longitudinal member 86 is shaped so as to define a distal forceapplicator 174 that extends distally, typically beyond screw thread 90.In the unlocked state, the force applicator extends through spool 46 andpushes against depressible portion 168 of locking mechanism 164. Thedepressible portion is thus pressed downward, as shown in FIG. 5,freeing protrusion 166 from within a recess 190 defined by structuralbarrier portions 188 of the lower portion of spool 46. Additionally,protrusion 166 is freed from within recessed portion 176 provided byspool housing 44. As a result, contracting mechanism 40 is unlocked, andspool 46 may be rotated with respect to spool housing 44.

Cap 170 functions to restrict distal pushing of depressible portion 168beyond a desired distance so as to inhibit deformation of lockingmechanism 164. For applications in which contracting mechanism 40 isimplanted in heart tissue, cap 170 also provides an interface betweencontracting mechanism 40 and the heart tissue. This preventsinterference of heart tissue on contracting mechanism 40 during thelocking and unlocking thereof. Additionally, cap 170 prevents damage toheart tissue by depressible portion 168 as it is pushed downward.

In the locked state shown in FIG. 7, protrusion 166 is positioned withina recess 190 of spool 46. Typically, the locked state is the restingstate of locking mechanism 162. Depressible portion 168 is disposed in ahorizontal position, in response to removal of distal force applicator174 from within spool 46. Depressible portion 168 has a tendency toassume the horizontal position, as shown, and in the absence of adownward pushing force applied to depressible portion 168 by forceapplicator 174, depressible portion 168 returns to its horizontalposition from its pushed-down state, as shown in FIG. 7. In thishorizontal position, protrusion 166 of locking mechanism 164 is removedfrom recessed portion 172 of cap 170 and is returned within a recess 190of spool 46 and thereby restricts movement of spool 46 and lockscontracting mechanism 40. Additionally, protrusion 166 of lockingmechanism 164 returns in part within recessed portion 176 of spoolhousing 44. Thus, recessed portion 176 of spool housing 44 providessupplemental locking of locking mechanism 164.

It is to be noted that although contracting mechanism 40 in FIG. 7 isshown without contracting member 30 for clarity of illustration,contracting member 30 is coupled to a portion of contracting mechanism40.

Reference is now made to FIGS. 8A-C, which are schematic illustrationsof a procedure for implanting implant structure 22 to repair mitralvalve 130, in accordance with an application of the present invention.The procedure is typically performed transluminally with the aid ofimaging, such as fluoroscopy, transesophageal echo, and/orechocardiography.

The procedure typically begins by advancing a semi-rigid guidewire (notshown) into a right atrium 120 of the patient. The guidewire provides aguide for the subsequent advancement of an access sheath 104 therealongand into the right atrium. Once sheath 104 has entered the right atrium,the guidewire is retracted from the patient's body. Sheath 104 typicallycomprises a 14-20 F sheath, although the size may be selected asappropriate for a given patient. Sheath 104 is advanced throughvasculature into the right atrium using a suitable point of origintypically determined for a given patient. For example:

sheath 104 may be introduced into the femoral vein of the patient,through an inferior vena cava 122, into right atrium 120, and into aleft atrium 124 transseptally, typically through the fossa ovalis;

sheath 104 may be introduced into the basilic vein, through thesubclavian vein to the superior vena cava, into right atrium 120, andinto left atrium 124 transseptally, typically through the fossa ovalis;

sheath 104 may be introduced into the external jugular vein, through thesubclavian vein to the superior vena cava, into right atrium 120, andinto left atrium 124 transseptally, typically through the fossa ovalis;or

sheath 104 may be introduced into left atrium 124 transatrially, e.g.,via the interatrial groove, or via the upper surface of the left atrium.

For some applications of the present invention, sheath 104 is advancedthrough an inferior vena cava 122 of the patient (as shown) and intoright atrium 120 using a suitable point of origin typically determinedfor a given patient.

Sheath 104 is advanced distally until the sheath reaches the interatrialseptum.

A resilient needle and a dilator (not shown) are advanced through sheath104 and into the heart. In order to advance sheath 104 transseptallyinto left atrium 124, the dilator is advanced to the septum, and theneedle is pushed from within the dilator and is allowed to puncture theseptum to create an opening that facilitates passage of the dilator andsubsequently sheath 104 therethrough and into left atrium 124. Thedilator is passed through the hole in the septum created by the needle.Typically, the dilator is shaped to define a hollow shaft for passagealong the needle, and the hollow shaft is shaped to define a tapereddistal end. This tapered distal end is first advanced through the holecreated by the needle. The hole is enlarged when the graduallyincreasing diameter of the distal end of the dilator is pushed throughthe hole in the septum.

The advancement of sheath 104 through the septum and into the leftatrium is followed by the extraction of the dilator and the needle fromwithin sheath 104.

Implant structure 22 (with anchor deployment manipulator 60 therein) isadvanced through sheath 104 into left atrium 124.

As shown in FIG. 8A, end 51 of sleeve 26 is positioned in a vicinity ofa left fibrous trigone 2 of an annulus 140 of mitral valve 130. (It isnoted that for clarity of illustration, end 51 of sleeve 26 is shownschematically in the cross-sectional view of the heart, although lefttrigone 2 is in reality not located in the shown cross-sectional plane,but rather out of the page closer to the viewer.) Alternatively, the tipis positioned in a vicinity of a right fibrous trigone 4 of the mitralvalve (configuration not shown). Further alternatively, end 51 of sleeve26 is not positioned in the vicinity of either of the trigones, but isinstead positioned elsewhere in a vicinity of the mitral valve, such asin a vicinity of the anterior or posterior commissure. For someapplications, outer tube 62 of anchor deployment manipulator 60 issteerable, as is known in the catheter art, while for otherapplications, a separate steerable tube is provided. In either case, thesteering functionality typically allows the area near the distal end ofthe deployment manipulator to be positioned with six degrees of freedom.Once positioned at the desired site near the selected trigone,deployment manipulator 60 deploys a first anchor 38 through the wall ofsleeve 26 into cardiac tissue near the trigone.

As shown in FIG. 8B, deployment manipulator 60 is repositioned alongannulus 140 to another site selected for deployment of a second anchor38. Typically, the first anchor is deployed most distally in the sleeve(generally at or within a few millimeters of the distal tip of thesleeve), and each subsequent anchor is deployed more proximally, suchthat the sleeve is gradually pulled off (i.e., withdrawn from) thedeployment manipulator in a distal direction during the anchoringprocedure. The already-deployed first anchor 38 holds the anchored endof sleeve 26 in place, so that the sleeve is drawn from the site of thefirst anchor towards the site of the second anchor. Typically, as sleeve26 is pulled off (i.e., withdrawn from) the deployment manipulator, thedeployment manipulator is moved generally laterally along the cardiactissue, as shown in FIG. 8B. Deployment manipulator 60 deploys thesecond anchor through the wall of sleeve 26 into cardiac tissue at thesecond site. Depending on the tension applied between the first andsecond anchor sites, the portion of sleeve 26 therebetween may remaintubular in shape, or may become flattened, which may help reduce anyinterference of implant structure 22 with blood flow.

For some applications, in order to provide the second and subsequentanchors, anchor driver 68 is withdrawn from the patient's body viasheath 104 (typically while leaving outer tube 62 of the deploymentmanipulator in place in the sleeve), provided with an additional anchor,and then reintroduced into the patient's body and into the outer tube.Alternatively, the entire deployment manipulator, including the anchordriver, is removed from the body and subsequently reintroduced uponbeing provided with another anchor. Further alternatively, deploymentmanipulator 60 is configured to simultaneously hold a plurality ofanchors, and to deploy them one at a time at the selected sites.

As shown in FIG. 8C, deployment manipulator 60 is repositioned along theannulus to additional sites, at which respective anchors are deployed,until the last anchor is deployed in a vicinity of right fibrous trigone4 (or left fibrous trigone 2 if the anchoring began at the righttrigone). Alternatively, the last anchor is not deployed in the vicinityof a trigone, but is instead deployed elsewhere in a vicinity of themitral valve, such as in a vicinity of the anterior or posteriorcommissure.

As described hereinabove with reference to FIGS. 6 and 7, rotation tool80 used to rotate spool 46 of contracting mechanism 40, in order totighten implant structure 22. (For clarity of illustration, contractingmember 30 of implant structure 22, although provided, is not shown inFIGS. 8A-C.)

For some applications, sleeve 26 is filled with a material (e.g.,polyester, polytetrafluoroethylene (PTFE), polyethylene terephthalate(PET), or expanded polytetrafluoroethylene (ePTFE)) after beingimplanted. The material is packed within at least a portion, e.g., 50%,75%, or 100%, of the lumen of sleeve 26. The filler material functionsto prevent (1) formation within the lumen of sleeve 26 of clots or (2)introduction of foreign material into the lumen which could obstruct thesliding movement of contracting member 30.

As described hereinabove with reference to FIGS. 3D-E, end 49 of sleeve26 is closed upon completion of the implantation procedure.Alternatively, the proximal end of the sleeve may have a naturaltendency to close when not held open by deployment manipulator 60.

Reference is made to FIG. 9, which is a schematic illustration of thedeployment of one of anchors 38 into cardiac tissue, in accordance withan application of the present invention. For these applications, one ormore (such as all) of anchors 38 are deployed from left atrium 124,through tissue of the atrial wall, and into tissue of an upper region ofthe ventricular wall 150 near the atrium. Because the tissue of theupper region of ventricular wall is thicker than that of the atrialwall, deploying the anchors into the upper region of the ventricularwall generally provides more secure anchoring. In addition, because theanchors are not deployed laterally through the atrial wall, the risk ofperforating the atrial wall is reduced.

FIGS. 10A-E are schematic illustrations of a system 220 comprising animplant structure 222 comprising sleeve 26 that defines a lumen forinsertion therethrough of a coiled element 240, in accordance with someapplications of the present invention. Implant structure 222 isgenerally similar to implant structure 22, as described hereinabove withreference to FIGS. 1, 2, 3A-F, 4-7, 8A-C, and 9, with the exception that(a) coiled element 240 (which comprises a contraction-restrictingelement 200) is advanced within the lumen of sleeve 26 during theimplantation procedure, as described hereinbelow, or is prepositioned inthe sleeve prior to commencement of the implantation procedure, and (b)implant structure 222 typically does not comprise crimping element(s) 32or 34.

Implant structure 222 is implanted along the annulus of the nativemitral valve in a manner as described hereinabove with reference toFIGS. 2, 3A-C, 8A-C, and 9, with regard to the implantation of implantstructure 22 along the annulus of the mitral valve.

Sleeve 26 of implant structure 222 is shaped so as to define an openingat proximal end 49 thereof. A contraction-restricting-elementadvancement tube 230 is advanced toward implant structure 222 through alumen of a delivery tube 232. It is to be noted that outer tube 62(shown in FIGS. 2 and 3A-C) of manipulator 60 may be advanced withindelivery tube 232 during the anchoring of implant structure 222 to theannulus. For some applications, advancement tube 230 may be slidablewithin sheath 104 (shown in FIGS. 8A-C and 9).

Advancement tube 230 is advanced within the lumen of sleeve 26 untildistal end 51 thereof. For some applications, delivery tube 232 is alsoadvanced within the lumen of sleeve 26 until distal end 51 thereof (notshown for clarity of illustration). As shown in FIG. 10B, advancementtube 230 houses an overtube 234 which, in turn, houses coiled element240. Coiled element 240 comprises a flexible material, e.g., nitinol,which is biased to assume the coiled shape shown in FIG. 10C. For someapplications in which the coiled element comprises such a flexiblematerial, coiled element 240 is disposed within overtube 234 in a statein which coiled element 240 is generally straightened from its coiledstate, i.e., at least partially uncoiled. In order to deploy element 240within the lumen of sleeve 26, overtube 234 is retracted in thedirection indicated by the arrow in FIG. 10B. For some applications, apusher (not shown) disposed within overtube 234 proximally to element240 pushes on element 240 as overtube 234 is retracted. During thedeployment of coiled element 240, successive portions of element 240 areexposed from within overtube 234 and assume the pre-determined coiledconfiguration, as shown.

As shown in FIG. 10C, coiled element 240 is advanced within the lumen ofsleeve 26 and comprises contraction-restricting element 200 andcontractible portions 201 a and 201 b. In its deployed configuration,i.e., its coiled configuration, element 240 is typically shaped so as todefine a diameter of between 2 and 6 mm, e.g., 3 mm. As shown in FIG.10D, following the advancement of coiled element 240 within the lumen ofsleeve 26, overtube 234, advancement tube 230, and delivery tube 232 areremoved from within the body of the patient, and the opening at proximalend 49 of implant structure 222 is typically closed, such as by closuremechanism 290. For some applications, closure mechanism 290 comprisesclosure mechanism 290, as described hereinabove with reference to FIGS.1 and 3D-E. For some applications, closure mechanism 290 comprisesclosure mechanism 290, as will be described hereinbelow with referenceto FIGS. 14A-B.

As shown in FIGS. 10C-D, contraction-restricting element 200 is a coiledportion of element 240 that is non-compressible, and contractibleportions 201 a and 201 b (that are coupled to, or flank,contraction-restricting element 200) are respective portions of element240 that are compressible. Contraction-restricting element 200 defines apitch that is smaller than that of portions 201 a and 201 b (as shown inthe blow-ups in FIG. 10D). Thus, if coiled element 240 were to bepositioned along a longitudinal axis, contraction-restricting element200 would restrict contraction of element 240 (and thereby implantstructure 222) along the longitudinal axis, while contractible portions201 a and 201 b would allow contraction of element 240 (and therebyimplant structure 222) along the longitudinal axis. When coiled element240 is positioned within the lumen of sleeve 26, as shown in FIGS.10C-D, (1) contraction-restricting element 200 definescontraction-restricted portion 52 of structure 222 that is disposedalong the portion of the annulus at posterior leaflet 14, and (2)contractible portions 201 a and 201 b define respectivecontraction-facilitated portions 53 a and 53 b of structure 222 that arecontractible and expandable in response to respective tightening orloosening of contracting member 30 (not shown for clarity ofillustration) responsively to the actuation of contracting mechanism 40.For some applications, contraction-restricting element 200 has a lengthof more than 3 mm and/or less than 120 mm (e.g., a length of 3 mm-120mm), and defines contraction-restricted portion 52, portion 52 having alength of more than 3 mm and/or less than 120 mm (e.g., a length of 3mm-120 mm). During the ongoing contraction of structure 222 responsivelyto the actuation of contracting mechanism 40, contractible portions 201a and 201 b facilitate longitudinal contraction of portions 53 a and 53b, respectively, while contraction-restricting element 200 restrictslongitudinal contraction of portion 52, but facilitates radial movementof portion 52 toward the center of the valve (i.e., in the direction asindicated by the arrows). This radial movement of portion 52 bringsleaflet 14 toward leaflet 12.

It is to be noted that one contraction-restricting element 200 and twocontractible portions 201 a and 201 b are shown in FIGS. 10A-D by way ofillustration and not limitation, and that coiled element 240 maycomprise any suitable number of elements 200 or portions 201. Forexample, in FIG. 10E coiled element 240 is shown, the coiled elementdefining two contraction-restricting elements 200 a and 200 b, and twocontractible portions 201 a and 201 b. When coiled element 240 ispositioned within the lumen of sleeve 26, as shown in FIG. 10E, (1)contraction-restricting element 200 a defines contraction-restrictedportion 52 a of structure 222 that is disposed along the portion of theannulus at posterior leaflet 14, (2) contraction-restricting element 200b defines contraction-restricted portion 52 b of structure 222 that isdisposed in a vicinity of trigone 4, and (3) contractible portions 201 aand 201 b define respective contraction-facilitated portions 53 a and 53b of structure 222 that are contractible and expandable in response torespective tightening or loosening of contracting member 30 (not shownfor clarity of illustration) responsively to the actuation ofcontracting mechanism 40. Typically, contraction-restricted portion 52 acomprises more than 10% (e.g., more than 20%), and/or less than 60%(e.g., less than 30%) of the resting length of coiled element 240. Forsome applications, each of contraction-facilitated portions 53 a and 53b comprises less than 50% (e.g., less than 20%, or less than 10%) of theresting length of coiled element 240. For some applications, the totallength of the contraction-facilitated portions of coiled element 240comprises less than 50%, e.g., less than 30%, of the resting length ofthe coiled element.

In the configuration shown in FIG. 10E, coiled element 240 defines twocontraction-restricting elements 200 a and 200 b, one of which isdisposed along the portion of the annulus at posterior leaflet 14, andone of which is disposed in a vicinity of one of the trigones. However,the scope of the present invention includes configurations in which thecoiled element defines three contraction-restricting elements 200, oneof which is disposed along the portion of the annulus at posteriorleaflet 14, and two of which are disposed in vicinities of respectivetrigones of the subject. For some applications, coiled element 240defines two contraction-restricting elements 200, which are disposed invicinities of respective trigones of the subject, e.g., as describedwith reference to FIG. 12.

For some applications, the implantable structures described herein areconfigured such that the contraction-restricted portions and thecontraction-facilitated portions of the implantable structures aredisposed adjacent to respective portions of the mitral annulus, so as tofacilitate reshaping of the mitral annulus in a desired manner. Thelengths of the contraction-restricted portions and thecontraction-facilitated portions typically correspond to thecorresponding portions of the mitral annulus. Typically, upon placementof the implantable structures described herein at the mitral annulus,contraction-restricted portions 52 and contraction-facilitated portions53 are asymmetrically disposed with respect to the mitral annulus.Further typically, lengths of the contraction-restricted portions andthe contraction-facilitated portions are not equal to one another.Alternatively, lengths of the contraction-restricted portions and thecontraction-facilitated portions are equal to one another.

Reference is again made to FIGS. 10A-E. It is to be noted that althoughsystem 220 is advanced and implanted within the heart of the patientusing a minimally-invasive procedure, any suitable procedure may be usedto advance and implant system 220, e.g., a transcatheter procedure or asurgical procedure, such as an open-heart surgical procedure.

Reference is now made to FIGS. 11A-D, which are schematic illustrationsof a system 250 that is similar to system 220 described hereinabove withreference to FIGS. 10A-E, with the exception that coiled element 240 isnot advanced within overtube 234, in accordance with some applicationsof the present invention. Coiled element 240 is instead advanceddirectly within the lumen of delivery tube 232 and into the lumen ofsleeve 26 in its coiled state, as shown in FIGS. 11A-C. Typically, apushing tube 236 slides within delivery tube 232 proximally to coiledelement 240 in order to push coiled element 240 from within the lumen ofdelivery tube 232 into sleeve 26. For some applications, delivery tube232 is advanced within the lumen of sleeve 26 until distal end 51thereof, and coiled element 240 is positioned within the lumen of sleeve26 when tube 232 is retracted and pushing tube 236 pushes on coiledelement 240.

Reference is now made to FIG. 12, which is a schematic illustration ofcoiled element 240, in accordance with some applications of the presentinvention. For some applications, techniques described herein arepracticed in combination with techniques described in U.S. patentapplication Ser. No. 12/341,960 to Cabiri (published as US2010/0161047), which is incorporated herein by reference. FIG. 12 isgenerally similar to FIG. 5 of the aforementioned Cabiri application.FIG. 12 shows a system 120 for repairing a dilated annulus of a subjectcomprising an annuloplasty structure 300 that defines an annuloplastyring, in accordance with some applications of the present invention.Annuloplasty structure 300 comprises first and second ends 302 and 304,respectively, which are coupled to (e.g., welded to) a housing 306 thathouses contracting mechanism 40 (which is generally as describedhereinabove). Housing 306 is shaped to provide first and second couplingmembers 308 and 310 which are coupled to first and second ends 302 and304, of structure 300, respectively.

For some applications, structure 300 comprises a linear, elongatestructure in a resting configuration thereof. Prior to implantation,first and second ends 302 and 304 of structure 300 are welded orotherwise attached to coupling members 308 and 310, respectively,thereby facilitating the formation of structure 300 into a substantiallyring-shaped structure. As described in U.S. patent application Ser. No.12/341,960 to Cabiri (published as US 2010/0161047), structure 300typically comprises a body portion (e.g., coiled element 240) defining alumen for housing flexible member 312. A first end of flexible member312 is coupled to contracting mechanism 40, while a second end offlexible member 312 is coupled to second end 304 of structure 300.

As shown, structure 300 defines a substantially ring-shapedconfiguration, e.g., a “D”-shaped configuration, as shown, whichconforms to the shape of the annulus of a mitral valve of the subject.Prior to contracting of structure 300, the coiled element 240 is relaxedand structure 300 defines a first perimeter thereof. Coiled elementprovides contraction-restricting elements 200 which comprise a materialin a configuration in which portions 49 are flexible and lesslongitudinally compressible, e.g., not longitudinally compressible, withrespect to contractible portion 201 of coiled element 240, for example,as described hereinabove. Contraction-restricting elements 200 areconfigured to be disposed in the vicinity of the trigones of the mitralvalve of the heart, e.g., along the fibrous portion of the annulus thatis between the trigones when structure 300 is anchored, sutured,fastened or otherwise coupled to the annulus of the mitral valve.Contraction-restricting elements 200 impart rigidity to structure 300 inthe portion thereof that is disposed between the fibrous trigones suchthat structure 300 better mimics the conformation and functionality ofthe mitral valve.

Typically, both contraction-restricting elements 200 have a combinedlength of 10-50 mm.

Structure 300 defines contractible portion 201 andcontraction-restricting elements 200. Typically, a radius of curvatureat a center of the contractible portion of coiled element 240 is smallerthan a radius of curvature at a center of contraction-restrictingelements 200, when no external force is applied to the annuloplastystructure.

It is to be noted that contractible portion 201 andcontraction-restricting elements 200 of structure 300 comprise a coiledelement by way of illustration and not limitation. For example,contractible portion 201 and contraction-restricting elements 200 maycomprise stent-like struts, or a braided mesh. In either configuration,contraction-restricting elements 200 are chronically longitudinallycompressed in a resting state of structure 300.

For some applications coiled element 240 is used in combination withimplant structures 222 and 250 (described with reference to FIGS.10A-11D), the coiled element defining two contraction-restrictingelements 200, which are disposed in vicinities of respective trigones ofthe subject, e.g., as described with reference to FIG. 12.

FIG. 13 is a schematic illustration of a system 260 comprising animplant structure 262 and contraction-restricting element 200 comprisinga contraction-restricting segment 268 that is coupled to an outersurface of sleeve 26, in accordance with some applications of thepresent invention. For some applications, segment 268 comprises a coiledelement, as described hereinabove. For other applications, segment 268comprises a tubular element comprising a material, e.g., a semi-rigidmaterial (such as nitinol, polyethylene, and/or silicone, e.g.,high-rigidity silicone), which restricts compression along alongitudinal axis of segment 268.

Typically, segment 268 is coupled to sleeve 26 by being sutured theretovia sutures 264, by way of illustration and not limitation, typicallybefore implant 262 is advanced within the body of the patient. Segment268 may be coupled to sleeve 26 using any suitable coupling technique.Segment 268 is typically coupled to sleeve 26 prior to advancing implant262 within the body of the patient.

Segment 268 is typically coupled to portion of sleeve 26 designated forimplantation along the annulus of the valve at posterior leaflet 14.Alternatively or additionally, segment 268 is coupled to a portion ofthe sleeve designated for implantation in a vicinity of one or bothtrigones 2 and 4. The coupling of segment 268 to the portion of sleeve26 defines contraction-restricted portion 52 of structure 262, while theremaining portions of sleeve 26 not coupled to segment 268 definecontraction-facilitated portions 53 a and 53 b of structure 262. Ingeneral, the techniques described hereinabove with respect tocontraction-restricting element 200, with reference to FIGS. 10A-12, maybe applied to segment 268, mutatis mutandis.

Implant structure 262 is generally similar to implant structure 22, asdescribed hereinabove with reference to FIGS. 1, 2, 3A-F, 4-7, 8A-C, and9, with the exception that contraction-restricting element 200 iscoupled to the outer surface of sleeve 26, and implant structure 262typically does not comprise crimping element(s) 32 or 34. Structure 262is typically implanted along the annulus in a manner as describedhereinabove with reference to FIGS. 2, 3A-C, 8A-C, and 9, with regard tothe implantation of implant structure 22 along the annulus of the mitralvalve.

Following the implantation of structure 262 along the annulus, portionsof implant structure 262 are contracted using contracting mechanism 40,as described hereinabove. During the ongoing contraction of structure262 responsively to the actuation of contracting mechanism 40,contraction-facilitated portions 53 a and 53 b are contracted, whilecontraction-restricting element 200 restricts longitudinal contractionof contraction-restricted portion 52, but facilitates radial movement ofportion 52 toward the center of the valve (i.e., in the direction asindicated by the arrows). This radial movement of portion 52 bringsleaflet 14 toward leaflet 12.

Following the contracting of structure 262 by mechanism 40, the openingat proximal end 49 of implant structure 262 may be closed, such as byclosure mechanism 290. For some applications, closure mechanism 290comprises closure mechanism 290, as described hereinabove with referenceto FIGS. 1 and 3D-E. For some applications, closure mechanism 290comprises closure mechanism 290, as will be described hereinbelow withreference to FIGS. 14A-B.

It is to be noted that although contraction-restricting segment 268 isshown in FIG. 13 as comprising a tubular element, for some applications,a different element, e.g., a suture, is used to definecontraction-restricted portion 52 of implant structure 262. For example,coiled element 240 may be placed inside sleeve 26. One or morecontraction-restricting elements (e.g., a suture, a staple, a ratchetmechanism, and/or a bracket) are placed around portions of the coiledelement, in order to decrease the pitch of the coiled element at theportions, thereby reducing the contractibility of the portions.

For some applications, a healthcare professional places thecontraction-restricting element around given portions of the coiledelement intra-procedurally, the portions of the coiled elementcorresponding to respective portions of a subject's mitral annulus. Forexample, subsequent to determining the size of the subject's mitralvalve, and before placing the implant structure inside the patient'sbody, the healthcare professional may place contraction-restrictingelement around given portions of the coiled element, in order to reducethe contractibility of the portions. For some applications, thehealthcare professional applies sutures to the coiled element while theelement is disposed inside a sizer. For some applications, the sizer isused to guide the suturing and to prevent the healthcare professionalfrom placing a suture through contracting member 30 (shown in FIG. 1,for example).

FIGS. 14A-B show a system 280 comprising an implant structure 281 andclosure mechanism 290 comprising self-closing strips 282 a and 282 b, inaccordance with some applications of the present invention Implantstructure 281 is generally similar to implant structure 22, as describedhereinabove with reference to FIGS. 1, 2, 3A-F, 4-7, 8A-C, and 9, withthe exception that closure mechanism 290 at proximal end 49 of structure281 comprises strips 282 a and 282 b and does not comprise crimpingelement(s) 32 or 34.

Strips 282 a and 282 b are typically coupled to (e.g., by being threadedthrough) portions of proximal end 49 of structure 281 in the vicinity ofopening 25. Strips 282 a and 282 b define generally arcuate elementswhich comprise a flexible material (e.g., nitinol). Strips 282 a and 282b have a tendency to close and assume the configuration shown in FIG.14B. Strips 282 a and 282 b are opened from their closed state when atool (e.g., such as manipulator 60, as shown, and described hereinabovewith reference to FIGS. 1, 2, 3A-C, 8A-C, 9, or delivery tube 232described hereinabove with reference to FIGS. 10A-E and 11A-D) isadvanced within the lumen of sleeve 26 (as shown in FIG. 14A). Once thetool is removed from within the lumen, strips 282 a and 282 b assumetheir biased state thereby closing opening 25 at proximal end 49 ofstructure 281. Thus, strips 282 are automatically-activatable when thedelivery tool is removed from the lumen of sleeve 26.

Strips 282 a and 282 b are coupled to respective strings 284 whichcouple strips 282 a and 282 b to sleeve 26. Strings 284 are crimpedtogether by a crimp 286.

As shown in FIG. 14A, manipulator 60 is advanceable within the lumen ofsleeve 26 so as to facilitate anchoring of structure 281 using anchors38, in a manner as described hereinabove with reference to FIGS. 2,3A-C, 8A-C, and 9, with regard to the implantation of implant structure22 along the annulus of the mitral valve. Following the anchoring,contracting mechanism 40 is actuated in order to adjust a dimension ofstructure 281. As described hereinabove, contracting mechanism 40adjusts a tension of contracting member 30 coupled thereto. Contractingmechanism 40 and contracting member 30 are coupled to sleeve 26, in amanner as described hereinabove with reference to FIG. 1. Sincecontracting member 30 is threaded through sleeve 26, as shown, theadjusting of the tension of contracting mechanism 30 adjusts thedimension of sleeve 26 and thereby, of implant structure 281. Followingthe adjusting, manipulator 60 is then removed from the body of thepatient, allowing strips 282 a and 282 b to close around opening 25, andstructure 281 remains within the heart. It is to be noted that structure281 may comprise the stiffening element described hereinabove withreference to FIGS. 1.

Reference is made to FIGS. 15A-C, which are schematics illustrations ofan exemplary configuration of one of anchors 38, in accordance with anapplication of the present invention. For some applications, each oftissue anchors 38 comprises a helical tissue coupling element 400, and atool-engaging head 402, fixed to one end of the tissue coupling element(the proximal end of the tissue coupling element, opposite the distalend that first penetrates the tissue). Anchor 38 comprises a hardmaterial, such as metal, e.g., steel, Nitinol, or stainless steelSS316LVM. Anchor 38 may be manufactured from a single piece of material,or coupling element 400 and tool-engaging head 402 may be manufacturedfrom separate pieces of material and fixed together.

Typically, helical tissue coupling element 400 has an inner diameter D3of at least 1.5 mm, no more than 2.5 mm, and/or between 1.5 and 2.5 mm,e.g., 1.8 mm, along an entire length thereof along a centrallongitudinal axis 410 of the anchor (although the inner diameter isshown as being constant along the entire length of coupling element 400,the inner diameter optionally varies along the length of the couplingelement). An outer diameter D4 of helical tissue coupling element 400may be, for example, at least 2.4 mm, no more than 5 mm, and/or between2.4 and 5 mm, e.g., 2.4 mm.

Tool-engaging head 402 is shaped so as to define an engaging opening 412that passes entirely through the tool-engaging head along axis 410. Theengaging opening is typically at least partially non-circular, such asin order to engage a rotating deployment element of a deployment tool.For example, as shown in FIGS. 15A-C, engaging opening 412 may be shapedso as to define a proximal non-circular internal engaging surface 420,and a distal circular non-engaging surface 422. Proximal engagingsurface 420 is shaped to engage a rotating deployment element, such thatrotation of the deployment element rotates tool-engaging head 402 andanchor 38. For example, proximal engaging surface 420 may be rectangular(e.g., square), teethed (e.g., defining a plurality of squares withwhich the rotating element can engage), star-shaped, polygonal (e.g.,octagonal), or any other appropriate non-circular shape.

A portion of the deployment element may pass partially or completelythrough distal non-engaging surface 422, without engaging this surface.The non-engaging surface may serve as a shoulder, which pushes againstthe tissue, providing resistance when the anchor has been sufficientlyscrewed into the tissue. Optionally, the deployment element does notpass entirely through distal non-engaging surface 422, such that thedeployment element does not press against or into the tissue.Alternatively, the deployment element may protrude slightly from thedistal non-engaging surface 422, when no force is applied to thedeployment element by the tissue. Optionally, when the anchor is pressedagainst the tissue, inner spaces in the tool-engagement head 402 of theanchor allow the deployment element to sink into the anchor, and notpress against the tissue. Engaging opening 412 typically has across-sectional area (perpendicular to axis 410) of at least 0.8 mm2,such as at least 1.2 mm2.

For some applications, a proximal-most portion 424 of helical tissuecoupling element 400, at the end which is fixed to tool-engaging head402, is generally straight and oriented generally parallel to axis 410,i.e., at angle of between 0 and 15 degrees with the axis, such as 0degrees. Proximal-most portion 424 typically has a length of between 0.5and 2 mm, such as about 1 mm.

The outer perimeter of tool-engaging head 402 is typically circular, andan outer diameter D5 of tool-engaging head 402 may be, for example, atleast 2 mm, no more than 7 mm, and/or between 2 and 7 mm, such asbetween 2.5 and 5 mm, e.g., 2.4 mm, 2.5 mm, or 3 mm.

The outer diameter of anchor 38 may be, for example, at least 2 mm, nomore than 7 mm, and/or between 2 and 7 mm, such as between 2.5 and 5 mm.The entire length of anchor 38, measured along axis 410, is typically atleast 2.5 mm, no greater than 10 mm, and/or between 2.5 and 10 mm, suchas between 3 and 4.5 mm. A length L1 of tissue coupling element 400,measured along axis 410, may be at least 2.5 mm, no greater than 10 mm,and/or between 2.5 and 10 mm, such as between 3 and 4.5 mm. Typically,helical tissue coupling element 400 has between 3 and 5 turns.

The proximal end of tissue coupling element 400 is typically fixed totool-engaging head 402 near the outer perimeter of the tool-engaginghead, such that the tissue coupling element does not block engagingopening 412. For example, as labeled in the top-view of the anchor inFIG. 15C, the tissue coupling element may be fixed to the tool-engaginghead such that one or more of the following dimension characterize theanchor:

-   -   a distance D7 between (a) a center 431 of the proximal end of        tissue coupling element 400 and (b) an outer perimeter of        tool-engaging head 402 is no more than 20% of a width D5 of        tool-engaging head 402 (the width is a diameter for applications        in which the head is circular), such as no more than 10% of        width D3. For example, distance D7 may be between 0.1 and 0.3        mm, e.g., 0.2 mm;    -   a distance D8 between (a) a most radially-inward portion 428 of        the proximal end of tissue coupling element 200 (i.e., the        portion of the proximal end that is closest to central        longitudinal axis 410 of the anchor) and (b) the outer perimeter        of tool-engaging head 202 is no more than 40% of width D5 of        tool-engaging head 202 (the width is a diameter for applications        in which the head is circular), such as no more than 30% of        width D5, or no more than 20% of width D5. For example, distance        D8 may be between 0.3 and 0.5 mm, e.g., 0.4 mm; and/or    -   a distance between (a) a most radially-outward portion 430 of        the proximal end of tissue coupling element 400 (i.e., the        portion of the proximal end that is furthest from central        longitudinal axis 410 of the anchor) and (b) the outer perimeter        of tool-engaging head 402 is no more than 10% of width D5 of        tool-engaging head 402 (the width is a diameter for applications        in which the head is circular), such as no more than 5% of width        D5, e.g., 0. For example, the distance may be between 0 and 0.1        mm, e.g., 0 mm.

Anchor 38, including both helical tissue coupling element 400 andtool-engaging head 402, is thus shaped so as to provide a channel alongthe entire length of the anchor, through which a flexible inner shaftcan pass, and through which a rotating deployment element can pass whenin its radially-compressed state. More generally, as shown in FIG. 15B,the channel is sized and shaped such that a right circular cylinder 432could be placed within the channel, coaxial with anchor 38 (i.e., theaxis of the cylinder coincides with central longitudinal axis 410 ofanchor 38), and along the entire length of the tissue anchor, thecylinder having a diameter D6 of at least 1 mm, such as at least 2 mm.It is to be understood that cylinder 432 is an abstract geometric shape,rather than an element of an embodiment of the invention, and, as such,is perfectly cylindrical, i.e., is not shaped so as to define anygrooves or other surface or internal anomalies. No portion of anchor 38intersects central longitudinal axis 410.

Reference is now made to FIGS. 1-15C Implant structures 22, 222, 262,281, and 300 may be advanced toward annulus 140 in any suitableprocedure, e.g., a transcatheter procedure, a percutaneous procedure, aminimally invasive procedure, or an open heart procedure (in which caseone or more elements of systems 20, 220, 250, 260, and 280 are typicallyrigid). Regardless of the approach, the procedure typically includes thetechniques described hereinabove with reference to FIGS. 8A-C and 9.

It is to be noted that the positioning of contraction-restrictingelement(s) 200 along implant structures 22, 222, 262, 281, and 300 isshown by way of illustration and not limitation, and thatcontraction-restricting element(s) 200 (and any amount thereof) may beplaced anywhere along implant structures 22, 222, 262, 281, and 300.

For some applications, following initial contraction of implantstructures 22, 222, 262, and 281 during the implantation procedure,implant structures 22, 222, 262, and 281 may be further contracted orrelaxed at a later time after the initial implantation, such as betweenseveral weeks and several months after the initial implantation. Usingreal-time monitoring, tactile feedback and optionally in combinationwith fluoroscopic imaging, a rotation tool or anchor driver 68 ofdeployment manipulator 60 is reintroduced into the heart and used tocontract or relax implant structures 22, 222, 262, and 281.

Although implant structures 22, 222, 262, and 281 has been describedhereinabove as comprising a partial annuloplasty ring, for someapplications of the present invention, implant structure 22 insteadcomprises a full annuloplasty ring. Implant structures 22, 222, 262, and281 may comprise an annular portion of a structure, a ring, or a partialring, which facilitate coupling thereto of a prosthetic valve whichreplaces the native atrioventricular valve. Typically, implantstructures 22, 222, 262, and 281 function to treat (e.g., facilitaterepair or replacement of) the native atrioventricular valve of thepatient.

For some applications of the present invention, systems 20, 220, 250,260, and 280 are used to treat an atrioventricular valve other than themitral valve, i.e., the tricuspid valve. For these applications, implantstructures 22, 222, 262, and 281, and other components of systems 20,220, 250, 260, and 280 described hereinabove as being placed in the leftatrium are instead placed in the right atrium. Although implantstructures 22, 222, 262, and 281 are described hereinabove as beingplaced in an atrium, for some application implant structures 22, 222,262, and 281 are instead placed in either the left or right ventricle.

Features of implant structures 22, 222, 262, 281, and 300 described withreference to respective figures are not limited to the prostheses shownin those figures. Rather, features of the implant structures shown inany of the figures could be used in combination with any of the otherfeatures described herein, mutatis mutandis. Examples of the featuresthat may be combined with each other include, but are not limited to:

-   -   crimping elements 32 and 34,    -   flap 27,    -   stiffening elements 36    -   coiled element 240,    -   contraction-restricting segment 268, and    -   self-closing strips 282 a and 282 b.

For some applications, the scope of the present invention includesembodiments described in the following applications, which areincorporated herein by reference. In an embodiment, techniques andapparatus described in one or more of the following applications arecombined with techniques and apparatus described herein:

-   -   PCT Publication WO 06/097931 to Gross et al., entitled, “Mitral        Valve treatment techniques,” filed Mar. 15, 2006;    -   U.S. Provisional Patent Application 60/873,075 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed Dec. 5, 2006;    -   U.S. Provisional Patent Application 60/902,146 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed Feb. 16,        2007;    -   U.S. Provisional Patent Application 61/001,013 to Gross et al.,        entitled, “Segmented ring placement,” filed Oct. 29, 2007;    -   PCT Publication WO 08/068756 to Gross et al., entitled,        “Segmented ring placement,” filed Dec. 5, 2007;    -   U.S. patent application Ser. No. 11/950,930 to Gross et al.,        entitled, “Segmented ring placement,” filed Dec. 5, 2007, which        published as US 2008/0262609;    -   U.S. patent application Ser. No. 12/435,291 to Maisano et al.,        entitled, “Adjustable repair chords and spool mechanism        therefor,” filed on May 4, 2009, which published as US        2010/0161041;    -   U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        entitled, “Annuloplasty ring with intra-ring anchoring,” filed        on May 7, 2009, which published as US 2010/0286767;    -   PCT Publication WO 10/004546 to Gross et al., entitled,

“Annuloplasty devices and methods of delivery therefor,” filed on Jun.15, 2009;

-   -   U.S. patent application Ser. No. 12/548,991 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        Sep. 21, 2009, which published as US 2010/0161042;    -   PCT Publication WO 10/073246 to Cabiri et al., entitled,        “Adjustable annuloplasty devices and mechanisms therefor,” filed        Dec. 22, 2009;    -   U.S. patent application Ser. No. 12/706,868 to Miller et al.,        entitled, “Actively-engageable movement-restriction mechanism        for use with an annuloplasty structure,” filed Feb. 17, 2010,        which published as US 2010/0211166;    -   PCT Publication WO/2010/128502 to Maisano et al., entitled,        “Implantation of repair chords in the heart,” filed May 4, 2010;    -   U.S. patent application Ser. No. 12/608,316 to Miller et al.,        entitled, “Tissue anchor for annuloplasty ring,” filed on Oct.        29, 2009, which published as U.S. Patent Application Publication        2011/0106247    -   U.S. patent application Ser. No. 12/689,693 to Hammer et al.,        entitled, “Deployment techniques for annuloplasty ring,” filed        on Jan. 19, 2010, which published as US Patent Application        Publication 2010/0280605; and/or    -   PCT Publication WO/2010/128503 to Zipory et al., entitled,        “Deployment techniques for annuloplasty ring and over-wire        rotation tool,” filed May 4, 2010.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

The invention claimed is:
 1. Apparatus, comprising an implant structureconfigured to treat a native atrioventricular valve of a patient, theimplant structure comprising: a sleeve having a lumen and at least onelumen end, the at least one lumen end being shaped so as to define anend opening; an end flap disposed in a vicinity of the at least onelumen end, the end flap being configured to cover the end opening; and acontracting mechanism coupled to the implant structure and configured to(a) contract at least a contraction-facilitated portion of the implantstructure, and (b) actuate the end flap so as to cover the end opening.2. The apparatus according to claim 1, wherein the implant structure hasa length of between 50 mm and 150 mm.
 3. The apparatus according toclaim 1, wherein the implant structure has a diameter of between 1 mmand 10 mm.
 4. The apparatus according to claim 1, wherein the implantstructure is configured to be implanted along an annulus of the nativeatrioventricular valve of the patient in a manner in which the implantstructure is formed into at least a portion of an annuloplasty ring. 5.The apparatus according to claim 1, wherein the implant structurefurther comprises a contracting member that is coupled to the sleeve andfacilitates contraction of the contraction-facilitated portion of theimplant structure, the contracting member having a first portion thereofthat is coupled to the contracting mechanism.
 6. The apparatus accordingto claim 5, wherein the contracting member is threaded through a wall ofthe sleeve one or more times to facilitate generally-even contraction ofthe implant structure.
 7. The apparatus according to claim 5, whereinthe implant structure further comprises one or morecontraction-restricting elements coupled to at least acontraction-restricted portion of the implant structure, the one or morecontraction-restricting elements being configured to restrictcontraction of at least the contraction-restricted portion of theimplant structure beyond a predetermined amount.
 8. The apparatusaccording to claim 7, wherein each one of the one or morecontraction-restricting elements comprises a segment having at least aportion thereof that is non-compressible along a longitudinal axis ofthe segment.
 9. The apparatus according to claim 8, wherein at least oneof the contraction-restricting elements comprises a coiled element, andwherein at least a portion of the coiled element is non-compressible.10. The apparatus according to claim 9, wherein the coiled elementcomprises a shape-memory material and is configured to be generallystraightened from a coiled state during delivery of the implantstructure to an implantation site of a body of the patient.
 11. Theapparatus according to claim 5, wherein the implant structure is shapedso as to define first and second free ends, wherein the implantstructure is configured to be implanted along an annulus of the nativeatrioventricular valve of the patient, and wherein in response toactuation of the contracting mechanism, the first and the second freeends of the implant structure are drawn toward one another.
 12. Theapparatus according to claim 11, wherein the native atrioventricularvalve is a mitral valve of the patient, wherein the implant structure isconfigured to be implanted along the annulus of the mitral valve,wherein the first end of the implant structure is configured to becoupled to a first location along the annulus in a vicinity of a firsttrigone adjacent to the mitral valve, and wherein the second end of theimplant structure is configured to be coupled to a second location alongthe annulus in a vicinity of a second trigone adjacent to the mitralvalve.
 13. The apparatus according to claim 1, wherein one edge of theend flap extends from the sleeve at the at least one lumen end.
 14. Theapparatus according to claim 1, wherein the implant structure comprisesexactly one end flap.
 15. The apparatus according to claim 1, whereinthe implant structure further comprises a contracting member that iscoupled to the sleeve and facilitates contraction of thecontraction-facilitated portion of the implant structure, thecontracting member having a first portion that is coupled to thecontracting mechanism, and a second portion that is looped through aportion of the end flap.
 16. A method, comprising: positioning animplant structure along an annulus of a native atrioventricular valve ofa patient, the implant structure including (a) a sleeve having a lumenand at least one lumen end, the at least one lumen end being shaped soas to define an end opening, (b) an end flap disposed in a vicinity ofthe at least one lumen end, and (c) a contracting mechanism coupled tothe implant structure; fastening at least part of the implant structureto the annulus; covering the end opening with the end flap; andactuating the contracting mechanism to (a) contract at least acontraction-facilitated portion of the implant structure, and (b)actuate the end flap so as to cover the end opening.
 17. The methodaccording to claim 16, further comprising restricting the contracting ofat least a second portion of the implant structure that is less than theentire implant structure, during ongoing contracting of thecontraction-facilitated portion of the implant structure.
 18. The methodaccording to claim 16, wherein actuating the contracting mechanismcomprises rotating a rotatable structure of the contracting mechanism,and wherein contracting the at least a contraction-facilitated portionof the implant structure comprises rotating the rotatable structure in afirst rotational direction.
 19. The method according to claim 16,wherein one edge of the end flap extends from the sleeve at the at leastone lumen end.
 20. The method according to claim 16, wherein the implantstructure includes exactly one end flap.
 21. The method according toclaim 16, wherein the implant structure further includes a contractingmember that is coupled to the sleeve and facilitates contraction of thecontraction-facilitated portion of the implant structure, thecontracting member having a first portion that is coupled to thecontracting mechanism, and a second portion that is looped through aportion of the end flap, and wherein actuating the contracting mechanismto actuate the end flap to cover the end opening comprises actuating thecontracting mechanism to pull the contracting member to close the endflap.
 22. Apparatus, comprising an implant structure configured to treata native atrioventricular valve of a patient, the implant structurecomprising: a sleeve having a lumen and at least one lumen end, the atleast one lumen end being shaped so as to define an end opening; aclosure element disposed in a vicinity of the at least one lumen end,the closure element being configured to facilitate closure of the endopening; and a contracting mechanism, which (a) is coupled to theimplant structure, (b) comprises a flexible elongated contractingmember, (c) is configured to contract at least a contraction-facilitatedportion of the implant structure by tightening the contracting member,and (d) comprises a locking mechanism, which (i) is disposed at alocation other than in the vicinity of the at least one lumen end, and(ii) when locked, prevents tightening and loosening of the contractingmember.
 23. The apparatus according to claim 22, wherein the apparatusfurther comprises a deployment manipulator tube, which is removablypositioned at least partially within the lumen of the sleeve, such thatthe deployment manipulator tube extends out of the end opening, therebypreventing closure of the end opening by the closure element.
 24. Theapparatus according to claim 23, wherein the implant structure furthercomprises one or more tissue anchors, and wherein the apparatus furthercomprises an anchor driver which is reversibly coupleable to the one ormore tissue anchors and which is configured to be at least partiallypositioned within the deployment manipulator tube, and, while sopositioned, to deploy the one or more tissue anchors through a wall ofthe sleeve.
 25. The apparatus according to claim 22, wherein thecontracting mechanism is arranged so as to pull the contracting memberin a direction from the end opening toward the locking mechanism. 26.The apparatus according to claim 22, wherein the at least one lumen endis a first lumen end, and the sleeve has a second lumen end at an end ofthe sleeve opposite the first lumen end, and wherein the lockingmechanism is positioned within 1 cm of the second lumen end of thesleeve.
 27. The apparatus according to claim 22, wherein the contractingmechanism further comprises a housing that houses the locking mechanism.28. A method comprising: positioning an implant structure along anannulus of a native atrioventricular valve of a patient, the implantstructure including (a) a sleeve having a lumen and at least one lumenend, the at least one lumen end being shaped so as to define an endopening, (b) a closure element disposed in a vicinity of the at leastone lumen end, and (c) a contracting mechanism, which (i) is coupled tothe implant structure and (ii) includes a flexible elongated contractingmember, and (d) includes a locking mechanism, which (i) is disposed at alocation other than in the vicinity of the at least one lumen end, and(ii) when locked, prevents tightening and loosening of the contractingmember; fastening at least part of the implant structure to the annulus;closing the end opening by actuating the closure element to close;contracting at least a contraction-facilitated portion of the implantstructure by actuating the contracting mechanism to tighten thecontracting member; and locking the locking mechanism.
 29. The methodaccording to claim 28, wherein the method further comprises, beforeclosing the end opening, fastening at least part of the implantstructure to the annulus by deploying one or more tissue anchors througha wall of the sleeve using an anchor driver which (a) is reversiblycoupled to the one or more tissue anchors and (b) is at least partiallypositioned within a deployment manipulator tube, which deploymentmanipulator tube is removably positioned at least partially within thelumen of the sleeve, such that the deployment manipulator tube extendsout of the end opening, thereby preventing closure of the end opening bythe closure element.
 30. The method according to claim 28, wherein thecontracting mechanism is arranged so as to pull the contracting memberin a direction from the end opening toward the locking mechanism, andwherein actuating the contracting mechanism to tighten the contractingmember comprises actuating the contracting mechanism to pull thecontracting member in the direction from the end opening toward thelocking mechanism.
 31. The method according to claim 28, wherein the atleast one lumen end is a first lumen end, and the sleeve has a secondlumen end at an end of the sleeve opposite the first lumen end, andwherein the locking mechanism is positioned within 1 cm of the secondlumen end of the sleeve.
 32. The method according to claim 28, whereinthe contracting mechanism further includes a housing that houses thelocking mechanism.